Instrument, Ent Manual Surgical

FDA product code LRC · 56 cleared devices

Class 1 Ear, Nose, Throat

Regulation: 21 CFR 874.4420
Review panel: EN
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1987-03-23 – 2023-05-25

LRC 2023-05-25

BB 8 Sinus Dilation Kit

Applicant Excelent, Inc.

K number K230258

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LRC 2022-02-04

VenSure LightGuide

Applicant Intersect Ent.

K number K212774

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LRC 2020-10-15

SINUSPRIME Dilation System

Applicant Stryker Ent

K number K201398

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LRC 2020-08-27

Next Generation Balloon Dilation System

Applicant Acclarent, Inc.

K number K201115

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LRC 2020-08-26

VenSure Balloon Device, VenSure Nav Balloon Device

Applicant Fiagon GmbH

K number K201472

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LRC 2020-01-03

Dillard Nasal Balloon Catheter

Applicant Intuit Medical Products, LLC

K number K181546

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LRC 2019-05-03

RELIEVA ULTIRRA Sinus Balloon Catheter

Applicant Acclarent, Inc.

K number K190525

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LRC 2018-12-20

Sinusway Dilation System

Applicant 3nt Medical , Ltd.

K number K181838

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LRC 2017-12-12

MESIRE - Balloon Sinus Dilatation System

Applicant M/S. Meril Life Sciences Private Limited

K number K172737

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LRC 2017-09-05

Relieva SpinPlus Nav Balloon Sinuplasty System

Applicant Acclarent, Inc.

K number K171687

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LRC 2016-10-24

Relieva UltirraNav Sinus Balloon Catheter

Applicant Acclarent, Inc.

K number K161698

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LRC 2016-06-29

Vent-Os Sinus Dilation family

Applicant Sinusys Corporation

K number K160770

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LRC 2016-02-12

Relieva Scout Multi-Sinus Dilation System

Applicant Acclarent, Inc.

K number K153341

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LRC 2013-12-20

PATHASSIST LIGHT SEEKER

Applicant Entellus Medical, Inc.

K number K133563

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LRC 2013-12-17

BLOM-SINGER ADJUSTABLE BI-FIANGED FISTULA PROSTHESIS

Applicant Helix Medical, LLC

K number K130736

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LRC 2013-12-09

VENT-OS SINUS DILATION SYSTEM

Applicant Sinusys Corporation

K number K133016

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LRC 2013-11-05

EM SINUS DILATION SYSTEM

Applicant Medtronic Xomed, Inc.

K number K132297

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LRC 2013-10-04

XPRESS MULTI-SINUS DILATION TOOL

Applicant Entellus Medical, Inc.

K number K132440

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LRC 2013-10-04

SINUS DILATION SYSTEM WITH CANNULATED INSTRUMENT

Applicant Arthrocare Corp.

K number K131709

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LRC 2013-06-11

PATHASSIST LED LIGHT FIBER

Applicant Entellus Medical, Inc.

K number K130503

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LRC 2012-11-05

RELIEVA SEEKER BALLOON SINUPLASTY SYSTEM

Applicant Acclarent, Inc.

K number K120280

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LRC 2012-08-29

SINUS DILATION SYSTEM

Applicant Entrigue Surgical, Inc.

K number K121351

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LRC 2012-08-22

XPRESS MULTI-SINUS DILATION TOOL

Applicant Entellus Medical, Inc.

K number K121943

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LRC 2012-05-17

XPRESS MULTI-SINUS DILATION TOOL

Applicant Entellus Medical, Inc.

K number K121174

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LRC 2012-04-27

PATHASSIST LIGHT FIBER

Applicant Entellus Medical, Inc.

K number K120962

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LRC 2012-04-02

PATHASSIT LIGHT SEEKER

Applicant Entellus Medical, Inc.

K number K120735

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LRC 2012-01-27

PATHASSIST LIGHT SEEKER

Applicant Entellus Medical, Inc.

K number K113522

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LRC 2011-12-21

XPRESS MULTI-SINUS DILATION TOOL

Applicant Entellus Medical, Inc.

K number K112506

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LRC 2011-10-11

RELIEVA SPIN SINUS DILATION SYSTEM

Applicant Acclarent, Inc.

K number K111875

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LRC 2011-09-15

PATHASSIST LIGHT FIBER

Applicant Entellus Medical, Inc.

K number K111763

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LRC 2011-08-22

RELIEVA SOLO ELITE SINUS BALLOON CATHETER

Applicant Acclarent, Inc.

K number K111254

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LRC 2011-06-14

ENTELLUS MEDICAL SINUS GUIDEWIRE

Applicant Entellus Medical, Inc.

K number K110739

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LRC 2011-06-07

ILLUMINATING SINUS SEEKER

Applicant Entellus Medical, Inc.

K number K110158

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LRC 2010-10-22

XPRESS BALLOON DEVICE

Applicant Entellus Medical, Inc.

K number K102003

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LRC 2010-02-05

ENTELLUS MEDICAL BALLOON DEVICE

Applicant Entellus Medical, Inc.

K number K093007

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LRC 2009-07-08

FINESS SINUS TREATMENT SYSTEM (ACCESS SHEATH COMPONENT)

Applicant Entellus Medical, Inc.

K number K091681

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LRC 2008-06-27

MODIFICATION TO ENTELLUS MEDICAL RS-SERIES SYSTEM

Applicant Entellus Medical, Inc.

K number K081542

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LRC 2008-04-08

ENTELLUS MEDICAL RS-SERIES SYSTEM

Applicant Entellus Medical, Inc.

K number K072302

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LRC 2006-08-18

RELIEVA SINUS BALLOON CATHETER

Applicant Acclarent, Inc.

K number K061903

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LRC 2005-08-31

RELIEVA SINUS BALLOON INFLATION DEVICE

Applicant Acclarent, Inc.

K number K052198

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LRC 2005-04-05

RELIEVA SINUS BALLOON DILATION CATHETER

Applicant Exploramed Nc1, Inc.

K number K043527

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LRC 1999-03-05

EXMOOR SUCTION CLEARANCE KIT

Applicant Exmoor Plastics , Ltd.

K number K990366

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LRC 1997-03-28

FAST TRACT TRANSTRACHEAL PROCEDURE KIT

Applicant L.W. Ward and Assoc., Inc.

K number K970018

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LRC 1994-09-02

EXMOOR SINGLE USE MYRINGOTOMES

Applicant Exmoor Plastics , Ltd.

K number K942745

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LRC 1994-08-24

SUCKER ENDS (ZOELLNER)

Applicant Exmoor Plastics , Ltd.

K number K942746

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LRC 1994-06-08

DISPOSABLE NASAL RONGEUR

Applicant United States Surgical, A Division of Tyco Healthc

K number K942064

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LRC 1994-06-08

DISPOSABLE NASAL SCISSOR

Applicant United States Surgical, A Division of Tyco Healthc

K number K942063

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LRC 1994-06-06

DISPOSABLE ENT PUNCH

Applicant United States Surgical, A Division of Tyco Healthc

K number K942065

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LRC 1994-03-23

FORCEPS, ENT INSTR, ENT MANUAL SURG RETRACT/ALL TYPE

Applicant Mahe-Medizintechnik

K number K933770

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LRC 1993-07-22

SYMBIOSIS ENT SURGICAL INSTRUMENTS

Applicant Symbiosis Corp.

K number K931793

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LRC 1993-03-19

HOUSE-BELLUCCI ALLIGATOR SCISSORS

Applicant Thomasville Medical Assoc.

K number K930292

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LRC 1992-05-15

ATMOS MIRROR WARMER

Applicant Jedmed Instrument Co.

K number K920988

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LRC 1989-06-22

'EXMOOR' SINGLE USE SUCTION TUBE

Applicant Exmoor Plastics , Ltd.

K number K892504

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LRC 1989-03-22

FLEXIBLE ENDOSCOPE 91-8200(90) AND 91-82100(135)

Applicant Xomed, Inc.

K number K884631

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LRC 1987-09-04

POREX OTOLOGY INSTRUMENTS

Applicant Porex Medical

K number K873044

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LRC 1987-03-23

'EXMOOR' MOFFAT-ROBINSON BONE PATE COLLECTOR

Applicant Exmoor Plastics , Ltd.

K number K864938

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