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Lavage, Jet

FDA product code FQH · 52 cleared devices

Class 2 General Hospital

Regulation: 21 CFR 880.5475
Review panel: HO
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1979-07-30 – 2026-02-25

FQH 2026-02-25

BD Surgiphor™ Antimicrobial Irrigation System (910110)

Applicant Becton, Dickinson and Company (BD)

K number K253996

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FQH 2026-02-20

BD Surgiphor™ 1000 mL Antimicrobial Irrigation System (910120)

Applicant Bd

K number K253445

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FQH 2023-06-15

ERBEJET® 2 System

Applicant Erbe Elektromedizin GmbH

K number K231023

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FQH 2023-05-25

Armis VeriCyn Wound Wash

Applicant Armis Biopharma, Inc.

K number K220759

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FQH 2023-05-16

VERSAJET Hydrosurgery System (III)

Applicant Smith & Nephew Medical Limited

K number K220964

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FQH 2022-10-14

BD Surgiphor™ Antimicrobial Irrigation System

Applicant Bd

K number K221504

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FQH 2022-09-22

Irrisept Antimicrobial Wound Lavage

Applicant Irrimax Corporation

K number K222804

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FQH 2022-05-31

IRRIGO Wound Wash Jet System

Applicant Inopro, Inc.

K number K210987

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FQH 2022-03-23

BD Surgiphor Antimicrobial Irrigation System

Applicant Becton, Dickinson and Company

K number K213616

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FQH 2021-05-28

Irrisept Antimicrobial Wound Lavage

Applicant Irrimax Corporation

K number K210536

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FQH 2020-12-14

Irrisept Wound Debridement and Cleansing System

Applicant Irrimax Corporation

K number K202222

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FQH 2020-10-23

SURGIPHOR Wound Irrigation System

Applicant Orthophor, LLC

K number K202071

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FQH 2020-01-23

Bactisure Wound Lavage

Applicant Next Science, LLC

K number K192349

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FQH 2016-09-07

Next Science Irrigation Solution

Applicant Next Science, LLC

K number K161165

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FQH 2012-08-21

HY-CHLO(TM)WOUND SCRUB

Applicant Patrin Pharma

K number K113312

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FQH 2011-12-14

EXSEPT SKIN AND WOUND CLEANSER WITH ANTIMICROBIAL PRESERVATIVE

Applicant Alcavis Hdc, LLC

K number K111313

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FQH 2011-08-01

VERSAJET II HYDROSURGERY SYSTEM CONSOLE / EXACT HANDPIECES / PLUS HANDPIECES, VERSAJET FOOTSWITCH

Applicant Smith & Nephew, Inc.

K number K110958

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FQH 2009-06-17

PREMIER STERILE SALINE WOUND WASH, MODELS 210 ML, WWM

Applicant Premier Brands of America, Inc.

K number K090848

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FQH 2009-05-27

EXSEPT WC ANTIMICROBIAL SKIN AND WOUND CLEANSER

Applicant Alcavis International, Inc.

K number K082858

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FQH 2009-02-04

IRRISEPT WOUND CLEANSING SYSTEM

Applicant Irrimax Corporation

K number K080779

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FQH 2007-10-31

ERBE ERBEJET 2 SYSTEM

Applicant Erbe USA, Inc.

K number K072404

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FQH 2006-04-12

VERSAJET HYDROSURGERY SYSTEM AND HANDPIECE

Applicant Smith & Nephew Wound Management

K number K060782

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FQH 2004-01-30

ERBE HELIX HYDRO-JET

Applicant Erbe USA, Inc.

K number K033590

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FQH 2003-05-09

HYDROCISION GENERAL SURGERY FLUIDJET SYSTEM

Applicant Hydrocision, Inc.

K number K021813

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FQH 2002-10-25

HELIX HYDRO-JET

Applicant Erbe USA, Inc.

K number K022613

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FQH 2001-10-10

HELIX HYDRO-JET

Applicant Andreas Pein Medizintechnik GmbH

K number K012464

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FQH 2001-06-22

MODIFICATION TO HYDROCISION DEBRIDEMENT SYSTEM

Applicant Hydrocision, Inc.

K number K011612

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FQH 2000-03-31

HYDROCISION DEBDRIDEMENT SYSTEM

Applicant Hydrocision, Inc.

K number K991383

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FQH 1998-11-13

BLOWER/MISTER

Applicant Cardiothoracic Systems, Inc.

K number K983135

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FQH 1998-01-06

CHASE ANASTOMOSIS VISUALIZATION DEVICE

Applicant Chase Medical, Inc.

K number K974568

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FQH 1997-12-16

FLEXVIEW CO2 BLOWER WITH MIST

Applicant Ethicon Endo-Surgery, Inc.

K number K973803

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FQH 1997-12-08

CLEARVIEW BLOWER/MISTER

Applicant Dlp, Inc.

K number K973485

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FQH 1997-10-29

ARTISAN PULSE LAVAGE SYSTEM

Applicant Howmedica Corp.

K number K972551

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FQH 1997-07-29

STRYKER INTERPULSE HANDPIECE SET, SPLASH SHIELDS, IRRIGATION AND SUCTION TIPS, RECHARGEABLE BATTERY PACK

Applicant Stryker Instruments

K number K972069

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FQH 1997-06-20

H.V. PULSE LAVAGE (L31 SERIES)

Applicant Global Medical Products, Inc.

K number K970916

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FQH 1995-09-19

STRYKER INTERPULSE HANDPIECE SET, IRRIGATION TIPS, SPLASH SHIELDS, CANAL VISION TIP, IRRIGATION & SUCTION TIPS

Applicant Stryker Instruments

K number K951666

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FQH 1994-07-19

SIMPULSE SOLO SUCTION IRRIGATOR

Applicant Davol Inc., Sub. C. R. Bard, Inc.

K number K942886

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FQH 1994-04-07

TOP GUN

Applicant Bio-Medical Devices, Inc.

K number K933742

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FQH 1993-06-11

BONE LAVAGE SYSTEM

Applicant Innovative Surgical Devices Corp.

K number K926337

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FQH 1993-01-29

RMI SURGICCAL SITE VISUALIZATION WAND

Applicant Research Medical, Inc.

K number K922083

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FQH 1991-11-01

SURGI-SPRAY O.R. IRRIGATION SYSTEM

Applicant Phoenix Surgical Products, Inc.

K number K913568

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FQH 1987-12-30

PHARMASEAL WOUND IRRIGATION DEVICE

Applicant American Pharmaseal Div. Ahsc

K number K874022

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FQH 1987-12-29

MICRO-AIRE PULSE LAVAGE

Applicant Micro-Aire Surgical Instruments, Inc.

K number K874504

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FQH 1987-11-06

EXCEL PULSED IRRIGATION/SUCTION SYSTEM

Applicant Stryker Corp.

K number K873466

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FQH 1986-05-19

SURGICAL IRRIGATION DEVICE (SID)/ARTHROSCOPIC SURG

Applicant Orthopaedic Devices , Ltd.

K number K854737

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FQH 1986-01-27

PULSE LAVAGE

Applicant Tava Surgical Instruments

K number K854543

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FQH 1983-03-29

DAVOL SURGICAL SUCTION IRRIGATION INSTR

Applicant C.R. Bard, Inc.

K number K830386

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FQH 1982-04-21

MICRO-AIRE DISPOSABLE MINI & MAXI LAVAG

Applicant Micro-Aire Surgical Instruments, Inc.

K number K820661

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FQH 1982-02-05

ACKRAD N-DO VAGE TUBE

Applicant Ackrad Laboratories

K number K813607

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FQH 1982-02-04

XOMED MICRO-IRRIGATOR

Applicant Xomed, Inc.

K number K813475

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FQH 1982-01-25

IRRIGATION SYRINGE

Applicant Karoco Intl.

K number K810185

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FQH 1979-07-30

EXETER BONE LAUAGE SYSTEM

Applicant Howmedica Corp.

K number K790811

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