ClearanceBrief
Panels › General Hospital › Product code FQH · Class 2

Lavage, Jet

Regulation 880.5475

2510(k)s in 12 months (53 all time)
0recalls in 12 months (29 all time)
11recalls that name a 510(k)
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Top companies in FQH

Company510(k)sRecalls
Zimmer Orthopaedic Surgical Products010
Stryker Instruments Division of Stryker Corporation07
Irrimax Corporation41
Coloplast Corp03
Erbe USA, Inc.30
Hydrocision, Inc.30
Bd20
Howmedica Corp.20
Micro-Aire Surgical Instruments, Inc.20
Next Science, LLC20
Decided510(k)Device and applicantCode
Feb 25, 2026K253996BD Surgiphor™ Antimicrobial Irrigation System (910110)
Becton, Dickinson and Company (BD)
FQH
Feb 20, 2026K253445BD Surgiphor™ 1000 mL Antimicrobial Irrigation System (910120)
Bd
FQH
Jun 15, 2023K231023ERBEJET® 2 System
Erbe Elektromedizin GmbH, DE
FQH
May 25, 2023K220759Armis VeriCyn Wound Wash
Armis Biopharma, Inc.
FQH
May 16, 2023K220964VERSAJET Hydrosurgery System (III)
Smith & Nephew Medical Limited, GB
FQH
Oct 14, 2022K221504BD Surgiphor™ Antimicrobial Irrigation System
Bd
FQH
Sep 22, 2022K222804Irrisept Antimicrobial Wound Lavage
Irrimax Corporation
FQH
May 31, 2022K210987IRRIGO Wound Wash Jet System
Inopro, Inc., CA
FQH
Mar 23, 2022K213616BD Surgiphor Antimicrobial Irrigation System
Becton, Dickinson and Company
FQH
May 28, 2021K210536Irrisept Antimicrobial Wound Lavage
Irrimax Corporation
FQH
Dec 14, 2020K202222Irrisept Wound Debridement and Cleansing System
Irrimax Corporation
FQH
Oct 23, 2020K202071SURGIPHOR Wound Irrigation System
Orthophor, LLC
FQH
Jan 23, 2020K192349Bactisure Wound Lavage
Next Science, LLC
FQH
Sep 7, 2016K161165Next Science Irrigation Solution
Next Science, LLC
FQH
Jul 15, 2015K143115The VersaJet II Hydrosurgery System
Smith & Nephew, Inc.
FQH
Aug 21, 2012K113312HY-CHLO(TM)WOUND SCRUB
Patrin Pharma
FQH
Dec 14, 2011K111313EXSEPT SKIN AND WOUND CLEANSER WITH ANTIMICROBIAL PRESERVATIVE
Alcavis Hdc, LLC
FQH
Aug 1, 2011K110958VERSAJET II HYDROSURGERY SYSTEM CONSOLE / EXACT HANDPIECES / PLUS HANDPIECES, VERSAJET FOOTSWITCH
Smith & Nephew, Inc.
FQH
Jun 17, 2009K090848PREMIER STERILE SALINE WOUND WASH, MODELS 210 ML, WWM
Premier Brands of America, Inc.
FQH
May 27, 2009K082858EXSEPT WC ANTIMICROBIAL SKIN AND WOUND CLEANSER
Alcavis International, Inc.
FQH
Feb 4, 2009K080779IRRISEPT WOUND CLEANSING SYSTEM
Irrimax Corporation
FQH
Oct 31, 2007K072404ERBE ERBEJET 2 SYSTEM
Erbe USA, Inc.
FQH
Apr 12, 2006K060782VERSAJET HYDROSURGERY SYSTEM AND HANDPIECE
Smith & Nephew Wound Management
FQH
Jan 30, 2004K033590ERBE HELIX HYDRO-JET
Erbe USA, Inc.
FQH
May 9, 2003K021813HYDROCISION GENERAL SURGERY FLUIDJET SYSTEM
Hydrocision, Inc.
FQH
Oct 25, 2002K022613HELIX HYDRO-JET
Erbe USA, Inc.
FQH
Oct 10, 2001K012464HELIX HYDRO-JET
Andreas Pein Medizintechnik GmbH
FQH
Jun 22, 2001K011612MODIFICATION TO HYDROCISION DEBRIDEMENT SYSTEM
Hydrocision, Inc.
FQH
Mar 31, 2000K991383HYDROCISION DEBDRIDEMENT SYSTEM
Hydrocision, Inc.
FQH
Nov 13, 1998K983135BLOWER/MISTER
Cardiothoracic Systems, Inc.
FQH
Jan 6, 1998K974568CHASE ANASTOMOSIS VISUALIZATION DEVICE
Chase Medical, Inc.
FQH
Dec 16, 1997K973803FLEXVIEW CO2 BLOWER WITH MIST
Ethicon Endo-Surgery, Inc.
FQH
Dec 8, 1997K973485CLEARVIEW BLOWER/MISTER
Dlp, Inc.
FQH
Oct 29, 1997K972551ARTISAN PULSE LAVAGE SYSTEM
Howmedica Corp.
FQH
Jul 29, 1997K972069STRYKER INTERPULSE HANDPIECE SET, SPLASH SHIELDS, IRRIGATION AND SUCTION TIPS, RECHARGEABLE BATTERY PACK
Stryker Instruments
FQH
Jun 20, 1997K970916H.V. PULSE LAVAGE (L31 SERIES)
Global Medical Products, Inc.
FQH
Sep 19, 1995K951666STRYKER INTERPULSE HANDPIECE SET, IRRIGATION TIPS, SPLASH SHIELDS, CANAL VISION TIP, IRRIGATION & SUCTION TIPS
Stryker Instruments
FQH
Jul 19, 1994K942886SIMPULSE SOLO SUCTION IRRIGATOR
Davol Inc., Sub. C. R. Bard, Inc.
FQH
Apr 7, 1994K933742TOP GUN
Bio-Medical Devices, Inc.
FQH
Jun 11, 1993K926337BONE LAVAGE SYSTEM
Innovative Surgical Devices Corp.
FQH
Jan 29, 1993K922083RMI SURGICCAL SITE VISUALIZATION WAND
Research Medical, Inc.
FQH
Nov 1, 1991K913568SURGI-SPRAY O.R. IRRIGATION SYSTEM
Phoenix Surgical Products, Inc.
FQH
Dec 30, 1987K874022PHARMASEAL WOUND IRRIGATION DEVICE
American Pharmaseal Div. Ahsc
FQH
Dec 29, 1987K874504MICRO-AIRE PULSE LAVAGE
Micro-Aire Surgical Instruments, Inc.
FQH
Nov 6, 1987K873466EXCEL PULSED IRRIGATION/SUCTION SYSTEM
Stryker Corp.
FQH
May 19, 1986K854737SURGICAL IRRIGATION DEVICE (SID)/ARTHROSCOPIC SURG
Orthopaedic Devices , Ltd.
FQH
Jan 27, 1986K854543PULSE LAVAGE
Tava Surgical Instruments
FQH
Mar 29, 1983K830386DAVOL SURGICAL SUCTION IRRIGATION INSTR
C.R. Bard, Inc.
FQH
Apr 21, 1982K820661MICRO-AIRE DISPOSABLE MINI & MAXI LAVAG
Micro-Aire Surgical Instruments, Inc.
FQH
Feb 5, 1982K813607ACKRAD N-DO VAGE TUBE
Ackrad Laboratories
FQH

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