Atlas FDA

FQH

53 FDA 510(k) clearances · Product code

93 daysmedian time to decision
340 days90th percentile
53clearances measured

FDA profile

Official device name
Lavage, Jet
Device class
Class II (moderate risk)
Regulation
21 CFR 880.5475
Medical specialty
General Hospital
Adverse events (MAUDE)
2021: 398 · 2022: 171 · 2023: 333 · 2024: 425 · 2025: 845 · 2026: 300
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
BD Surgiphor™ Antimicrobial Irrigation System (910110) (K253996)Becton, Dickinson and Company (BD)2026-02-25
BD Surgiphor™ 1000 mL Antimicrobial Irrigation System (910120) (K253445)Bd2026-02-20
ERBEJET® 2 System (K231023)Erbe Elektromedizin GmbH2023-06-15
Armis VeriCyn Wound Wash (K220759)Armis Biopharma, Inc.2023-05-25
VERSAJET Hydrosurgery System (III) (K220964)Smith & Nephew Medical Limited2023-05-16
BD Surgiphor™ Antimicrobial Irrigation System (K221504)Bd2022-10-14
Irrisept Antimicrobial Wound Lavage (K222804)Irrimax Corporation2022-09-22
IRRIGO Wound Wash Jet System (K210987)Inopro, Inc.2022-05-31
BD Surgiphor Antimicrobial Irrigation System (K213616)Becton, Dickinson and Company2022-03-23
Irrisept Antimicrobial Wound Lavage (K210536)Irrimax Corporation2021-05-28
Irrisept Wound Debridement and Cleansing System (K202222)Irrimax Corporation2020-12-14
SURGIPHOR Wound Irrigation System (K202071)Orthophor, LLC2020-10-23
Bactisure Wound Lavage (K192349)Next Science, LLC2020-01-23
Next Science Irrigation Solution (K161165)Next Science, LLC2016-09-07
The VersaJet II Hydrosurgery System (K143115)Smith & Nephew, Inc.2015-07-15
HY-CHLO(TM)WOUND SCRUB (K113312)Patrin Pharma2012-08-21
EXSEPT SKIN AND WOUND CLEANSER WITH ANTIMICROBIAL PRESERVATIVE (K111313)Alcavis Hdc, LLC2011-12-14
VERSAJET II HYDROSURGERY SYSTEM CONSOLE / EXACT HANDPIECES / PLUS HANDPIECES, VERSAJET FOOTSWITCH (K110958)Smith & Nephew, Inc.2011-08-01
PREMIER STERILE SALINE WOUND WASH, MODELS 210 ML, WWM (K090848)Premier Brands of America, Inc.2009-06-17
EXSEPT WC ANTIMICROBIAL SKIN AND WOUND CLEANSER (K082858)Alcavis International, Inc.2009-05-27
IRRISEPT WOUND CLEANSING SYSTEM (K080779)Irrimax Corporation2009-02-04
ERBE ERBEJET 2 SYSTEM (K072404)Erbe USA, Inc.2007-10-31
VERSAJET HYDROSURGERY SYSTEM AND HANDPIECE (K060782)Smith & Nephew Wound Management2006-04-12
ERBE HELIX HYDRO-JET (K033590)Erbe USA, Inc.2004-01-30
HYDROCISION GENERAL SURGERY FLUIDJET SYSTEM (K021813)Hydrocision, Inc.2003-05-09
HELIX HYDRO-JET (K022613)Erbe USA, Inc.2002-10-25
HELIX HYDRO-JET (K012464)Andreas Pein Medizintechnik GmbH2001-10-10
MODIFICATION TO HYDROCISION DEBRIDEMENT SYSTEM (K011612)Hydrocision, Inc.2001-06-22
HYDROCISION DEBDRIDEMENT SYSTEM (K991383)Hydrocision, Inc.2000-03-31
BLOWER/MISTER (K983135)Cardiothoracic Systems, Inc.1998-11-13
CHASE ANASTOMOSIS VISUALIZATION DEVICE (K974568)Chase Medical, Inc.1998-01-06
FLEXVIEW CO2 BLOWER WITH MIST (K973803)Ethicon Endo-Surgery, Inc.1997-12-16
CLEARVIEW BLOWER/MISTER (K973485)Dlp, Inc.1997-12-08
ARTISAN PULSE LAVAGE SYSTEM (K972551)Howmedica Corp.1997-10-29
STRYKER INTERPULSE HANDPIECE SET, SPLASH SHIELDS, IRRIGATION AND SUCTION TIPS, RECHARGEABLE BATTERY PACK (K972069)Stryker Instruments1997-07-29
H.V. PULSE LAVAGE (L31 SERIES) (K970916)Global Medical Products, Inc.1997-06-20
STRYKER INTERPULSE HANDPIECE SET, IRRIGATION TIPS, SPLASH SHIELDS, CANAL VISION TIP, IRRIGATION & SUCTION TIPS (K951666)Stryker Instruments1995-09-19
SIMPULSE SOLO SUCTION IRRIGATOR (K942886)Davol Inc., Sub. C. R. Bard, Inc.1994-07-19
TOP GUN (K933742)Bio-Medical Devices, Inc.1994-04-07
BONE LAVAGE SYSTEM (K926337)Innovative Surgical Devices Corp.1993-06-11
RMI SURGICCAL SITE VISUALIZATION WAND (K922083)Research Medical, Inc.1993-01-29
SURGI-SPRAY O.R. IRRIGATION SYSTEM (K913568)Phoenix Surgical Products, Inc.1991-11-01
PHARMASEAL WOUND IRRIGATION DEVICE (K874022)American Pharmaseal Div. Ahsc1987-12-30
MICRO-AIRE PULSE LAVAGE (K874504)Micro-Aire Surgical Instruments, Inc.1987-12-29
EXCEL PULSED IRRIGATION/SUCTION SYSTEM (K873466)Stryker Corp.1987-11-06
SURGICAL IRRIGATION DEVICE (SID)/ARTHROSCOPIC SURG (K854737)Orthopaedic Devices , Ltd.1986-05-19
PULSE LAVAGE (K854543)Tava Surgical Instruments1986-01-27
DAVOL SURGICAL SUCTION IRRIGATION INSTR (K830386)C.R. Bard, Inc.1983-03-29
MICRO-AIRE DISPOSABLE MINI & MAXI LAVAG (K820661)Micro-Aire Surgical Instruments, Inc.1982-04-21
ACKRAD N-DO VAGE TUBE (K813607)Ackrad Laboratories1982-02-05
XOMED MICRO-IRRIGATOR (K813475)Xomed, Inc.1982-02-04
IRRIGATION SYRINGE (K810185)Karoco Intl.1982-01-25
EXETER BONE LAUAGE SYSTEM (K790811)Howmedica Corp.1979-07-30

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Every clearance here is in the API, with alerts when new ones post.