Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Instrument, Ultrasonic Surgical

FDA product code LFL · 151 cleared devices

Class U Unknown

Review panel: SU
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1980-11-18 – 2026-07-30

LFL 2026-07-30

neXus Ultrasonic Surgical Aspirator System

Applicant Misonix, LLC

K number K261448

View details →

LFL 2025-10-08

CUSA® Clarity Ultrasonic Surgical Aspirator System

Applicant Integra LifeSciences Corporation

K number K251162

View details →

LFL 2025-06-18

SanAgile™ Ultrasonic Surgery Advanced Portable Controller (SA10); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD14); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD23); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD36); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD45)

Applicant Shanghai Saints Sages Surgical Co., Ltd.

K number K242894

View details →

LFL 2025-03-24

Sonopet iQ Ultrasonic Aspirator System (5500-050-000)

Applicant Stryker Instruments

K number K243930

View details →

LFL 2024-11-18

Tenex 2nd Generation System

Applicant Trice Medical, Inc.

K number K241700

View details →

LFL 2024-07-11

CUSA® Clarity Ultrasonic Surgical Aspirator System

Applicant Integra LifeSciences Corporation

K number K240493

View details →

LFL 2024-06-18

Ultrasonic Surgical System

Applicant Hunan Handlike Minimally Invasive Surgery Co., Ltd.

K number K233036

View details →

LFL 2023-07-11

CUSA Clarity Ultrasonic Surgical Aspirator System

Applicant Integra LifeSciences Corporation

K number K230427

View details →

LFL 2023-06-23

neXus Ultrasonic Surgical Aspirator System

Applicant Misonix, LLC, A Bioventus Company

K number K231117

View details →

LFL 2023-02-28

HARMONIC 700 Shears

Applicant Ethicon Endo-Surgery, LLC

K number K221790

View details →

LFL 2023-02-16

Sonopet 1Q 3 7cm 1Q Large

Applicant Stryker Corporation

K number K223770

View details →

LFL 2022-12-15

LOTUS Series 4 Enhanced Shears, LOTUS Series 5

Applicant Sra Developments, Ltd.

K number K221102

View details →

LFL 2022-09-30

Ultrasonic Surgical System

Applicant Miconvey Technologies Co., Ltd.

K number K210567

View details →

LFL 2022-08-22

CUSA Clarity Ultrasonic Surgical Aspirator System

Applicant Integra LifeSciences Corporation

K number K221835

View details →

LFL 2022-07-28

neXus Ultrasonic Surgical Aspirator System

Applicant Misonix, Inc.

K number K221235

View details →

LFL 2022-07-18

Ultrasonic Scalpel System

Applicant Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.

K number K212614

View details →

LFL 2022-07-15

CUSA Clarity Ultrasonic Surgical Aspirator System

Applicant Integra LifeSciences Corporation

K number K221763

View details →

LFL 2022-03-08

Oclet TDS 1000

Applicant Tendonova Corporation

K number K212049

View details →

LFL 2022-02-03

Sonopet iQ Ultrasonic Aspirator System

Applicant Stryker Corporation

K number K213824

View details →

LFL 2021-12-13

neXus Ultrasonic Surgical Aspirator System

Applicant Misonix, Inc.

K number K212060

View details →

LFL 2021-11-15

Sonicision 7 Curved Jaw Cordless Ultrasonic Dissection Device

Applicant Covidien, LLC

K number K212301

View details →

LFL 2021-09-27

Ultrasonic Surgical Aspirator System, Model: XD880B

Applicant Smtp Technology Co., Ltd.

K number K212750

View details →

LFL 2021-08-04

Ultrasonic Bipolar Generator USG-410 with accessories

Applicant Olympus Medical Systems Corporation

K number K211838

View details →

LFL 2021-05-21

Harmonic Hand Piece, Blue, Harmonic Hand Piece, Gray

Applicant Ethicon Endo-Surgery, LLC

K number K211273

View details →

LFL 2021-05-21

Ultrasonic Surgical Aspirator System

Applicant Smtp Technology Co., Ltd.

K number K202299

View details →

LFL 2020-07-10

Sonicision Cordless Ultrasonic Dissector

Applicant Covidien, LLC

K number K200427

View details →

LFL 2020-06-23

CUSA Clarity Ultrasonic Surgical Aspirator System

Applicant Integra LifeSciences Corporation

K number K200774

View details →

LFL 2020-06-19

Kogent Torus Ultrasonic Aspirator

Applicant Katalyst Surgical, LLC

K number K192963

View details →

LFL 2020-02-28

HARMONIC HD 1000i Shears, 20 cm length, HARMONIC HD 1000i Shears, 36 cm length

Applicant Ethicon Endo-Surgery, LLC

K number K191555

View details →

LFL 2019-10-31

Ultrasonic Surgical System

Applicant Medisonic Technology CO

K number K190281

View details →

LFL 2019-05-30

neXus Ultrasonic Surgical Aspirator System

Applicant Misonix, Inc.

K number K190160

View details →

LFL 2019-04-11

Sonopet iQ Ultrasonic Aspirator System

Applicant Stryker Corporation

K number K190070

View details →

LFL 2019-04-01

CUSA Clarity Ultrasonic Surgical Aspirator System

Applicant Integra LifeSciences Corporation

K number K190180

View details →

LFL 2018-12-07

CUSA Clarity Ultrasonic Surgical Aspirator System

Applicant Integra LifeSciences Corporation

K number K182809

View details →

LFL 2018-08-28

Tenex Health TX System with the TXP MicroTip

Applicant Tenex Health, Inc.

K number K181367

View details →

LFL 2018-03-26

Sonicision Reusable Generator, Sonicision Reusable Battery Pack, Sonicision Curved Jaw Dissectors (multiple lengths), Sonicision Battery Charger, Sonicision Battery Insertion Guide

Applicant Covidien, LLC

K number K180149

View details →

LFL 2017-10-04

Ultrasonic Generator

Applicant Olympus Medical Systems Corp.

K number K172691

View details →

LFL 2017-09-28

CUSA Excel+ Ultrasonic Surgical Aspirator System

Applicant Integra LifeSciences Corporation

K number K172595

View details →

LFL 2016-10-14

CUSA Clarity Ultrasonic Surgical Aspirator System

Applicant Integra LifeSciences Corporation

K number K161882

View details →

LFL 2016-06-29

HARMONIC HD 1000i Shears 20 cm Length, HARMONIC HD 1000i Shears 36 cm Length

Applicant Ethicon Endo-Suregery, LLC

K number K160752

View details →

LFL 2016-03-28

Sonicision Cordless Ultrasonic Dissection Device

Applicant Covidien, LLC

K number K153371

View details →

LFL 2016-03-04

HARMONIC HOOK

Applicant Ethicon Endo-Surgery, LLC

K number K151136

View details →

LFL 2016-03-03

Tenex Health TX System

Applicant Tenex Health, Inc.

K number K153299

View details →

LFL 2013-12-16

HARMONIC ACE CURVED SHEARS WITH ERGONOMIC HANDLE

Applicant Ethicon Endo-Surgery, LLC

K number K132522

View details →

LFL 2013-12-03

HARMONIC FOCUS SHEARS + ADAPTIVE TISSUE TECHNOLOGY

Applicant Ethicon Endo-Surgery, LLC

K number K133314

View details →

LFL 2013-10-24

HARMONIC ACE CURVED SHEARS WITH SCISSOR HANDLE, HARMONIC ACE CURVED SHEARS WITH ERGONOMIC HANDLE

Applicant Ethicon Endo-Surgery, LLC

K number K132512

View details →

LFL 2013-10-17

HARMONIC ACE+ SHEARS 23 CM LENGTH WITH ADVANCED HEMOSTASIS, HARMONIC ACE + LAPAROSCOPIC SHEARS 36 CM LENGTH WITH ADVANCE

Applicant Ethicon Endo-Surgery, LLC

K number K132612

View details →

LFL 2013-03-20

TX1 TISSUE REMOVAL SYSTEM

Applicant Tenex Health

K number K123640

View details →

LFL 2012-08-22

HARMONIC ACE LAPAROSCOPIC 5MM DIAMETER SHEARS 36CM LENGTH + ADAPTIVE TISSUE TECHNOLOGY

Applicant Ethicon Endo-Surgery, LLC

K number K121550

View details →

LFL 2012-05-17

HARONIS ACE LAPAROSCOPIC 5MM DIAMETER SHEARS 36CM LENGTH +ADAPTIVE TISSUE TECHNOLOGY HARMONIC ACE 5MM DIAMETER SHEARS 23

Applicant Ethicon Endo-Surgery, LLC

K number K120729

View details →

LFL 2012-02-22

INTEGRA CUSA NXT INFERIOR FOWARD BONE TIP

Applicant Integra Burlington Ma, Inc.

K number K113570

View details →

LFL 2011-08-23

INTEGRA(TM) CUSA NXT(TM) BONE TIPS

Applicant Integra Burlington Ma, Inc. (Formerly Integra Radi

K number K111741

View details →

LFL 2011-06-10

CUSA NXT EXTENDED LENGTH TIP

Applicant Integra Radionics, Inc.

K number K102258

View details →

LFL 2011-02-24

SONICISION CORDLESS ULTRASONIC DISSECTION DEVICE MODEL SCD391, SCD396, SCT12, SCG, SCB, SCSK, SONICISION STERILIZATION T

Applicant Covidien, Formerly Valleylab, A Division of Tyco

K number K101797

View details →

LFL 2010-08-27

TX1 TISSUE REMOVAL SYSTEM

Applicant American Optisurgical, Inc.

K number K101561

View details →

LFL 2010-04-07

HARMONIC FOCUS SHEARS

Applicant Ethicon Endo-Surgery, LLC

K number K100597

View details →

LFL 2009-05-08

CUSA SHEAR TIP, AN ACCESSORY OF THE CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEM

Applicant Integra Radionics, Inc.

K number K090864

View details →

LFL 2008-08-13

CUSA SELECTOR NXT ULTRASONIC TISSUE ABLATION SYSTEM

Applicant Integra Radionics, Inc.

K number K081459

View details →

LFL 2008-05-21

SONOCA 180/195 WOUND CARE SYSTEM

Applicant Soering GmbH

K number K072904

View details →

LFL 2007-09-25

HARMONIC 10CM COMBINATION HOOK BLADE

Applicant Ethicon Endo-Surgery, LLC

K number K072203

View details →

LFL 2007-08-17

INTEGRA SELECTOR ULTRASONIC SURGICAL ASPIRATOR SYSTEM WITH BONE TIP

Applicant Integra Radionics, Inc.

K number K071669

View details →

LFL 2007-08-07

KIRWAN DISPOSABLE 23KHZ MANIFOLD TUBING, 40-3600, & 36KHZ MANIFOLD TUBING, 40-3601

Applicant Kirwan Surgical Products, Inc.

K number K070360

View details →

LFL 2007-05-11

MISONIX, INC., AUSS-7 ULTRASONIC SURGICAL ASPIRATOR SYSTEM

Applicant Misonix, Inc.

K number K070313

View details →

LFL 2007-02-22

SERIES 3 LOTUS LAPAROSCOPIC ULTRASOUND SURGERY SYSTEM

Applicant Sra Developments, Ltd.

K number K063531

View details →

LFL 2007-01-30

HARMONIC FOCUS CURVED SHEARS AND TORQUE WRENCH, HARMONIC BLUE HAND PIECE AND TEST TIP

Applicant Ethicon Endo-Surgery, LLC

K number K063192

View details →

LFL 2007-01-03

AR1000 ULTRASONIC WOUND THERAPY SYSTEM

Applicant Arobella Medical, LLC

K number K062544

View details →

LFL 2006-10-26

ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL FS 1000 RF

Applicant Misonix, Inc.

K number K062471

View details →

LFL 2006-09-25

HARMONIC WAVE COAGULATING SHEARS WITH SCISSOR HANDEL AND HAND CONTROL, MODEL WAVE18S; HARMONIC DISPOSABLE TORQUE WRENCH

Applicant Ethicon Endo-Surgery, Inc.

K number K062000

View details →

LFL 2006-04-07

HARMONIC SCALPEL BLADES AND SHEARS

Applicant Ethicon Endo-Surgery, Inc.

K number K060245

View details →

LFL 2006-01-19

HARMONIC SCALPEL BLADES AND SHEARS

Applicant Ethicon Endo-Surgery, Inc.

K number K053056

View details →

LFL 2005-08-22

RADIONICS CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEM WITH BONE

Applicant Radionics, A Division of Tyco Healthcare Group LP

K number K051947

View details →

LFL 2005-06-06

AUSS-6 ULTRASONIC SURGICAL ASPIRATOR SYSTEM

Applicant Misonix, Inc.

K number K050776

View details →

LFL 2005-06-03

OLYMPUS ULTRASONIC SURGICAL SYSTEM SONOSURG

Applicant Olympus Medical Systems Corporation

K number K050885

View details →

LFL 2005-06-02

HARMONIC ACE CURVED SHEARS WITH PISTOL HANDLE AND HAND CONTROL, MODEL ACE23P, ACE36P

Applicant Ethicon Endo-Surgery, Inc.

K number K051036

View details →

LFL 2005-01-25

SONOSURG TROCAR

Applicant Aomori Olympus Co., Ltd.

K number K042160

View details →

LFL 2004-12-01

HARMONIC ACE CURVED SHEARS WITH HAND CONTROL, MODEL ACE23P, ACE36P

Applicant Ethicon Endo-Surgery, Inc.

K number K042777

View details →

LFL 2004-09-29

SELECTOR QUANTUM ULTRASONIC ASPIRATOR SYSTEM

Applicant Integra Neurosciences, Ltd.

K number K042277

View details →

LFL 2004-09-08

SONOSURG ULTRASONIC SURGICAL SYSTEM

Applicant Aomori Olympus Co., Ltd.

K number K041566

View details →

LFL 2003-12-16

LOTUS

Applicant Sra Developments, Ltd.

K number K032424

View details →

LFL 2003-12-09

MISONIX INC. FS 1000 RF ULTRASONIC SURGICAL ASPIRATOR SYSTEM

Applicant Misonix, Inc.

K number K032690

View details →

LFL 2003-10-03

SONOSURG SYSTEM

Applicant The Olympus Optical Co.

K number K032066

View details →

LFL 2003-10-01

OLYMPUS ULTRASONIC SURGICAL SYSTEM

Applicant Aomori Olympus Co., Ltd.

K number K031523

View details →

LFL 2003-09-23

OLYMPUS ULTRASONIC SURGICAL SYSTEM

Applicant Olympus Optical Co., Ltd.

K number K031305

View details →

LFL 2003-08-29

OLYMPUS ULTRASONIC SURGICAL SYSTEM

Applicant Aomori Olympus Co., Ltd.

K number K031710

View details →

LFL 2003-02-12

OLYMPUS ULTRASONIC SURGICAL SYSTEM

Applicant The Olympus Optical Co.

K number K021962

View details →

LFL 2002-09-13

SELECTOR INTEGRA ULTRASONIC SURGICAL ASPIRATOR, MODEL OM 1530000M3

Applicant Integra Neurosciences

K number K021989

View details →

LFL 2002-09-10

AXYA MEDICAL, INC, MODEL 100 SONIC SCALPEL ULTRASONIC SURGICAL SYSTEM

Applicant Axya Medical, Inc.

K number K021929

View details →

LFL 2002-08-23

ULTRASONIC STRAIGHT/ULTRASONIC KNIFE/ULTRASONIC RING CURRETTE

Applicant Synergetics, Inc.

K number K020220

View details →

LFL 2001-11-13

SORING GMBH SONOCA 180/190

Applicant Soring GmbH Medizintechnik

K number K012753

View details →

LFL 2001-10-01

ULTRACISION HARMONIC SCALPEL BLADES WITH PROTECTIVE SLEEVE, MODELS DH105, DH145, SH105, SH145

Applicant Ethicon Endo-Surgery, Inc.

K number K012176

View details →

LFL 2001-07-27

ALLIGER ULTRASONIC SURGICAL SYSTEM MODEL AUSS-5

Applicant Misonix, Inc.

K number K012028

View details →

LFL 2001-05-31

ULTRACISION HARMONIC SCALPEL BLADES, MODEL DH105,DH145,SH105, SH145,HC145

Applicant Ethicon Endo-Surgery, Inc.

K number K010898

View details →

LFL 2001-04-20

SONOTOME ULTRASONIC ASPIRATOR TIPS

Applicant Synergetics, Inc.

K number K010637

View details →

LFL 2001-04-18

SONOPET MODEL UST-2001 ULTRASONIC SURGICAL ASPIRATOR

Applicant Mutoh America Co., Ltd.

K number K010309

View details →

LFL 2001-03-08

OMNISONICS ULTRASONIC SURGERY SYSTEM, MODEL STI

Applicant Omnisonics Medical Technologies

K number K003824

View details →

LFL 2000-12-15

ULTRACISION HARMONIC SCALPEL SYSTEM, MODELS GEN01, GEN02, GEN03, HP052, HP053, HSA07

Applicant Ethicon Endo-Surgery, Inc.

K number K002906

View details →

LFL 2000-10-10

ALLIGER ULTRASONIC SURGICAL SYSTEM MODEL AUSS-4

Applicant Misonix, Inc.

K number K000927

View details →

LFL 2000-09-26

OLYMPUS SONOSURG TROCAR XT3900 SYSTEM

Applicant The Olympus Optical Co.

K number K000095

View details →

LFL 2000-03-17

ULTRACISION HARMONIC SCALPEL SHARP CURVED BLADE/FAST BLADE, MODEL HF105

Applicant Ethicon Endo-Surgery, Inc.

K number K994280

View details →

LFL 1999-12-21

THE SOUNDVASER DISSECTION SYSTEM

Applicant Sound Surgical Technologies, LLC

K number K993868

View details →

↑