Product Code: FQH FDA class 2 21 CFR 880.5475

Lavage, Jet

General Hospital

The Jet Lavage device uses a pressurized stream of fluid to irrigate and cleanse wounds, body cavities, or surgical sites, removing debris, bacteria, and necrotic tissue to promote healing. It is classified as FDA Class 2 (moderate risk) and requires 510(k) premarket notification. The product code is FQH, regulated under 21 CFR 880.5475 in the General Hospital specialty.

View on FDA

510(k)s

FEI Numbers

146

Registration Numbers

146

Unique Applicants

Years Active

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Basic Information

Product Code: FQH
Device Class: FDA class 2
Regulation Number: 880.5475
Medical Specialty: General Hospital
Review Panel: HO
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 53 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K253996	BD Surgiphor Antimicrobial Irrigation System (910110)	Feb 25, 2026	Substantially Equivalent	Becton, Dickinson and Company (BD)
K253445	BD Surgiphor 1000 mL Antimicrobial Irrigation System (910120)	Feb 20, 2026	Substantially Equivalent	Bd
K231023	ERBEJET® 2 System	Jun 15, 2023	Substantially Equivalent	Erbe Elektromedizin GmbH
K220759	Armis VeriCyn Wound Wash	May 25, 2023	Substantially Equivalent	Armis Biopharma, Inc.
K220964	VERSAJET Hydrosurgery System (III)	May 16, 2023	Substantially Equivalent	Smith & Nephew Medical Limited
K221504	BD Surgiphor Antimicrobial Irrigation System	Oct 14, 2022	Substantially Equivalent	Bd
K222804	Irrisept Antimicrobial Wound Lavage	Sep 22, 2022	Substantially Equivalent	Irrimax Corporation
K210987	IRRIGO Wound Wash Jet System	May 31, 2022	Substantially Equivalent	Inopro, Inc.
K213616	BD Surgiphor Antimicrobial Irrigation System	Mar 23, 2022	Substantially Equivalent	Becton, Dickinson and Company
K210536	Irrisept Antimicrobial Wound Lavage	May 28, 2021	Substantially Equivalent	Irrimax Corporation
K202222	Irrisept Wound Debridement and Cleansing System	Dec 14, 2020	Substantially Equivalent	Irrimax Corporation
K202071	SURGIPHOR Wound Irrigation System	Oct 23, 2020	Substantially Equivalent	Orthophor, LLC
K192349	Bactisure Wound Lavage	Jan 23, 2020	Substantially Equivalent	Next Science, LLC
K161165	Next Science Irrigation Solution	Sep 07, 2016	Substantially Equivalent	Next Science, LLC
K143115	The VersaJet II Hydrosurgery System	Jul 15, 2015	Substantially Equivalent	Smith & Nephew, Inc.
K113312	HY-CHLO(TM)WOUND SCRUB	Aug 21, 2012	Substantially Equivalent	Patrin Pharma
K111313	EXSEPT SKIN AND WOUND CLEANSER WITH ANTIMICROBIAL PRESERVATIVE	Dec 14, 2011	Substantially Equivalent	Alcavis Hdc, LLC
K110958	VERSAJET II HYDROSURGERY SYSTEM CONSOLE / EXACT HANDPIECES / PLUS HANDPIECES, VERSAJET FOOTSWITCH	Aug 01, 2011	Substantially Equivalent	Smith & Nephew, Inc.
K090848	PREMIER STERILE SALINE WOUND WASH, MODELS 210 ML, WWM	Jun 17, 2009	Substantially Equivalent	Premier Brands of America, Inc.
K082858	EXSEPT WC ANTIMICROBIAL SKIN AND WOUND CLEANSER	May 27, 2009	Substantially Equivalent	Alcavis International, Inc.
K080779	IRRISEPT WOUND CLEANSING SYSTEM	Feb 04, 2009	Substantially Equivalent	Irrimax Corporation
K072404	ERBE ERBEJET 2 SYSTEM	Oct 31, 2007	Substantially Equivalent	Erbe USA, Inc.
K060782	VERSAJET HYDROSURGERY SYSTEM AND HANDPIECE	Apr 12, 2006	Substantially Equivalent	Smith & Nephew Wound Management
K033590	ERBE HELIX HYDRO-JET	Jan 30, 2004	Substantially Equivalent	Erbe USA, Inc.
K021813	HYDROCISION GENERAL SURGERY FLUIDJET SYSTEM	May 09, 2003	Substantially Equivalent	Hydrocision, Inc.
K022613	HELIX HYDRO-JET	Oct 25, 2002	Substantially Equivalent	Erbe USA, Inc.
K012464	HELIX HYDRO-JET	Oct 10, 2001	Substantially Equivalent	Andreas Pein Medizintechnik GmbH
K011612	MODIFICATION TO HYDROCISION DEBRIDEMENT SYSTEM	Jun 22, 2001	Substantially Equivalent	Hydrocision, Inc.
K991383	HYDROCISION DEBDRIDEMENT SYSTEM	Mar 31, 2000	Substantially Equivalent	Hydrocision, Inc.
K983135	BLOWER/MISTER	Nov 13, 1998	Substantially Equivalent	Cardiothoracic Systems, Inc.
K974568	CHASE ANASTOMOSIS VISUALIZATION DEVICE	Jan 06, 1998	Substantially Equivalent	Chase Medical, Inc.
K973803	FLEXVIEW CO2 BLOWER WITH MIST	Dec 16, 1997	Substantially Equivalent	Ethicon Endo-Surgery, Inc.
K973485	CLEARVIEW BLOWER/MISTER	Dec 08, 1997	Substantially Equivalent	Dlp, Inc.
K972551	ARTISAN PULSE LAVAGE SYSTEM	Oct 29, 1997	Substantially Equivalent	Howmedica Corp.
K972069	STRYKER INTERPULSE HANDPIECE SET, SPLASH SHIELDS, IRRIGATION AND SUCTION TIPS, RECHARGEABLE BATTERY PACK	Jul 29, 1997	Substantially Equivalent	Stryker Instruments
K970916	H.V. PULSE LAVAGE (L31 SERIES)	Jun 20, 1997	Substantially Equivalent	Global Medical Products, Inc.
K951666	STRYKER INTERPULSE HANDPIECE SET, IRRIGATION TIPS, SPLASH SHIELDS, CANAL VISION TIP, IRRIGATION & SUCTION TIPS	Sep 19, 1995	Substantially Equivalent	Stryker Instruments
K942886	SIMPULSE SOLO SUCTION IRRIGATOR	Jul 19, 1994	Substantially Equivalent	Davol Inc., Sub. C. R. Bard, Inc.
K933742	TOP GUN	Apr 07, 1994	Substantially Equivalent	Bio-Medical Devices, Inc.
K926337	BONE LAVAGE SYSTEM	Jun 11, 1993	Substantially Equivalent	Innovative Surgical Devices Corp.
K922083	RMI SURGICCAL SITE VISUALIZATION WAND	Jan 29, 1993	Substantially Equivalent	Research Medical, Inc.
K913568	SURGI-SPRAY O.R. IRRIGATION SYSTEM	Nov 01, 1991	Substantially Equivalent	Phoenix Surgical Products, Inc.
K874022	PHARMASEAL WOUND IRRIGATION DEVICE	Dec 30, 1987	Substantially Equivalent	American Pharmaseal Div. Ahsc
K874504	MICRO-AIRE PULSE LAVAGE	Dec 29, 1987	Substantially Equivalent	Micro-Aire Surgical Instruments, Inc.
K873466	EXCEL PULSED IRRIGATION/SUCTION SYSTEM	Nov 06, 1987	Substantially Equivalent	Stryker Corp.
K854737	SURGICAL IRRIGATION DEVICE (SID)/ARTHROSCOPIC SURG	May 19, 1986	Substantially Equivalent	Orthopaedic Devices , Ltd.
K854543	PULSE LAVAGE	Jan 27, 1986	Substantially Equivalent	Tava Surgical Instruments
K830386	DAVOL SURGICAL SUCTION IRRIGATION INSTR	Mar 29, 1983	Substantially Equivalent	C.R. Bard, Inc.
K820661	MICRO-AIRE DISPOSABLE MINI & MAXI LAVAG	Apr 21, 1982	Substantially Equivalent	Micro-Aire Surgical Instruments, Inc.
K813607	ACKRAD N-DO VAGE TUBE	Feb 05, 1982	Substantially Equivalent	Ackrad Laboratories
K813475	XOMED MICRO-IRRIGATOR	Feb 04, 1982	Substantially Equivalent	Xomed, Inc.
K810185	IRRIGATION SYRINGE	Jan 25, 1982	Substantially Equivalent	Karoco Intl.
K790811	EXETER BONE LAUAGE SYSTEM	Jul 30, 1979	Substantially Equivalent	Howmedica Corp.