Lavage, Jet
FDA product code FQH · Class II (moderate risk) · 21 CFR 880.5475 · General Hospital
53510(k) clearances
0PMA approvals
29recalls
Manufacturers
- Irrimax Corporation 4
- Hydrocision, Inc. 3
- Erbe USA, Inc. 3
- Bd 2
- Micro-Aire Surgical Instruments, Inc. 2
- Smith & Nephew, Inc. 2
- Stryker Instruments 2
- Howmedica Corp. 2
- Next Science, LLC 2
- Phoenix Surgical Products, Inc. 1
- Ethicon Endo-Surgery, Inc. 1
- Dlp, Inc. 1
- Bio-Medical Devices, Inc. 1
- Innovative Surgical Devices Corp. 1
- Research Medical, Inc. 1
- Becton, Dickinson and Company (BD) 1
- Stryker Corporation 1
- Orthopaedic Devices , Ltd. 1
- C.R. Bard, Inc. 1
- Ackrad Laboratories 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253996 | BD Surgiphor Antimicrobial Irrigation System (910110)FQH · Special | Becton, Dickinson and Company (BD) | 02/25/2026SE |
| K253445 | BD Surgiphor 1000 mL Antimicrobial Irrigation System (910120)FQH · Traditional | Bd | 02/20/2026SE |
| K231023 | ERBEJET® 2 SystemFQH · Traditional | Erbe Elektromedizin GmbH | 06/15/2023SE |
| K220759 | Armis VeriCyn Wound WashFQH · Traditional | Armis Biopharma, Inc. | 05/25/2023SE |
| K220964 | VERSAJET Hydrosurgery System (III)FQH · Traditional | Smith & Nephew Medical Limited | 05/16/2023SE |
| K221504 | BD Surgiphor Antimicrobial Irrigation SystemFQH · Traditional | Bd | 10/14/2022SE |
| K222804 | Irrisept Antimicrobial Wound LavageFQH · Special | Irrimax Corporation | 09/22/2022SE |
| K210987 | IRRIGO Wound Wash Jet SystemFQH · Traditional | Inopro, Inc. | 05/31/2022SE |
| K213616 | BD Surgiphor Antimicrobial Irrigation SystemFQH · Traditional | Becton, Dickinson and Company | 03/23/2022SE |
| K210536 | Irrisept Antimicrobial Wound LavageFQH · Traditional | Irrimax Corporation | 05/28/2021SE |
| K202222 | Irrisept Wound Debridement and Cleansing SystemFQH · Traditional | Irrimax Corporation | 12/14/2020SE |
| K202071 | SURGIPHOR Wound Irrigation SystemFQH · Traditional | Orthophor, LLC | 10/23/2020SE |
| K192349 | Bactisure Wound LavageFQH · Traditional | Next Science, LLC | 01/23/2020SE |
| K161165 | Next Science Irrigation SolutionFQH · Traditional | Next Science, LLC | 09/07/2016SE |
| K143115 | The VersaJet II Hydrosurgery SystemFQH · Traditional | Smith & Nephew, Inc. | 07/15/2015SE |
| K113312 | Hy-Chlo(Tm)Wound ScrubFQH · Traditional | Patrin Pharma | 08/21/2012SE |
| K111313 | Exsept Skin and Wound Cleanser with Antimicrobial PreservativeFQH · Traditional | Alcavis Hdc, LLC | 12/14/2011SE |
| K110958 | Versajet II Hydrosurgery System Console / Exact Handpieces / Plus Handpieces, Versajet…FQH · Traditional | Smith & Nephew, Inc. | 08/01/2011SE |
| K090848 | Premier Sterile Saline Wound Wash, Models 210 ML, WWMFQH · Traditional | Premier Brands of America, Inc. | 06/17/2009SE |
| K082858 | Exsept WC Antimicrobial Skin and Wound CleanserFQH · Traditional | Alcavis International, Inc. | 05/27/2009SE |
| K080779 | Irrisept Wound Cleansing SystemFQH · Traditional | Irrimax Corporation | 02/04/2009SE |
| K072404 | Erbe Erbejet 2 SystemFQH · Abbreviated | Erbe USA, Inc. | 10/31/2007SE |
| K060782 | Versajet Hydrosurgery System and HandpieceFQH · Traditional | Smith & Nephew Wound Management | 04/12/2006SE |
| K033590 | Erbe Helix Hydro-JetFQH · Traditional | Erbe USA, Inc. | 01/30/2004SE |
| K021813 | Hydrocision General Surgery Fluidjet SystemFQH · Traditional | Hydrocision, Inc. | 05/09/2003SE |
| K022613 | Helix Hydro-JetFQH · Traditional | Erbe USA, Inc. | 10/25/2002SE |
| K012464 | Helix Hydro-JetFQH · Abbreviated | Andreas Pein Medizintechnik GmbH | 10/10/2001SE |
| K011612 | Modification to Hydrocision Debridement SystemFQH · Special | Hydrocision, Inc. | 06/22/2001SE |
| K991383 | Hydrocision Debdridement SystemFQH · Traditional | Hydrocision, Inc. | 03/31/2000SE |
| K983135 | Blower/MisterFQH · Traditional | Cardiothoracic Systems, Inc. | 11/13/1998SE |
| K974568 | Chase Anastomosis Visualization DeviceFQH · Traditional | Chase Medical, Inc. | 01/06/1998SE |
| K973803 | Flexview CO2 Blower with MistFQH · Traditional | Ethicon Endo-Surgery, Inc. | 12/16/1997SE |
| K973485 | Clearview Blower/MisterFQH · Traditional | Dlp, Inc. | 12/08/1997SE |
| K972551 | Artisan Pulse Lavage SystemFQH · Traditional | Howmedica Corp. | 10/29/1997SE |
| K972069 | Stryker Interpulse Handpiece Set, Splash Shields, Irrigation and Suction Tips…FQH · Traditional | Stryker Instruments | 07/29/1997SE |
| K970916 | H.V. Pulse Lavage (L31 Series)FQH · Traditional | Global Medical Products, Inc. | 06/20/1997SE |
| K951666 | Stryker Interpulse Handpiece Set, Irrigation Tips, Splash Shields, Canal Vision Tip…FQH · Traditional | Stryker Instruments | 09/19/1995SE |
| K942886 | Simpulse Solo Suction IrrigatorFQH · Traditional | Davol Inc., Sub. C. R. Bard, Inc. | 07/19/1994SE |
| K933742 | Top GunFQH · Traditional | Bio-Medical Devices, Inc. | 04/07/1994SE |
| K926337 | Bone Lavage SystemFQH · Traditional | Innovative Surgical Devices Corp. | 06/11/1993SE |
| K922083 | Rmi Surgiccal Site Visualization WandFQH · Traditional | Research Medical, Inc. | 01/29/1993SE |
| K913568 | Surgi-Spray O.R. Irrigation SystemFQH · Traditional | Phoenix Surgical Products, Inc. | 11/01/1991SE |
| K874022 | Pharmaseal Wound Irrigation DeviceFQH · Traditional | American Pharmaseal Div. Ahsc | 12/30/1987SE |
| K874504 | Micro-Aire Pulse LavageFQH · Traditional | Micro-Aire Surgical Instruments, Inc. | 12/29/1987SE |
| K873466 | Excel Pulsed Irrigation/Suction SystemFQH · Traditional | Stryker Corp. | 11/06/1987SE |
| K854737 | Surgical Irrigation Device (Sid)/Arthroscopic SurgFQH · Traditional | Orthopaedic Devices , Ltd. | 05/19/1986SE |
| K854543 | Pulse LavageFQH · Traditional | Tava Surgical Instruments | 01/27/1986SE |
| K830386 | Davol Surgical Suction Irrigation InstrFQH · Traditional | C.R. Bard, Inc. | 03/29/1983SE |
| K820661 | Micro-Aire Disposable Mini & Maxi LavagFQH · Traditional | Micro-Aire Surgical Instruments, Inc. | 04/21/1982SE |
| K813607 | Ackrad N-Do Vage TubeFQH · Traditional | Ackrad Laboratories | 02/05/1982SE |
| K813475 | Xomed Micro-IrrigatorFQH · Traditional | Xomed, Inc. | 02/04/1982SE |
| K810185 | Irrigation SyringeFQH · Traditional | Karoco Intl. | 01/25/1982SE |
| K790811 | Exeter Bone Lauage SystemFQH · Traditional | Howmedica Corp. | 07/30/1979SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1794-2024 Class II | Medtronic Clearview Blower/Mister, Model Number 22120Potential for unsealed sterile packing. | Medtronic Perfusion Systems | 03/19/2024Open, Classified |
| Z-1787-2022 Class III | DERMARITE INDUSTRIES SafeWash Saline Saline Wound Flush SafeWash 7.1 oz. Can Sterile…Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher… | Mckesson Medical-Surgical Inc. Corporate… | 05/25/2022Open, Classified |
| Z-0191-2020 Class II | Irrisept Wound Debridement and Cleansing System. 12 units per case.Potential defect in the sterile pouch seal, which may result in a lack of sterility assurance. | IrriMAX Corporation | 08/16/2019Terminated |
| Z-0983-2019 Class II | AXIUS Blower Mister Product Code/REF Number: CB-1000 The Axius Blower Mister is intended…Potential lack of carbon dioxide (CO2) flow that may result in a procedural delay during off-pump coronary… | Maquet Cardiovascular, LLC | 01/24/2019Terminated |
| Z-1246-2018 Class II | 1. InterPulse Handpiece with coaxial bone cleaning tip, Product Number: 0210-110-100…Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates. | Stryker Instruments Div. of Stryker… | 11/09/2017Terminated |
| Z-0490-2019 Class II | Irrisept OR, Finished Bottle Assembly 450 ml STEP 1Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. | Medex Cardio-Pulmonary Inc., d.b.a. Smiths… | 09/05/2017Terminated |
| Z-2062-2015 Class II | 0210-312-000-Woundcare Replacement kit with soft tip; 0210-318-000; Woundcare…Potential sterility breach in the packaging. | Stryker Instruments Div. of Stryker… | 05/08/2015Terminated |
| Z-2231-2015 Class II | Medical Device Exchange FEMORAL CANAL TIP; Pouch, Tyvek/Mylar, Sterile, Single Use Only…EXP did not register as a medical device establishment, list the devices being recalled, or establish its… | EXP Pharmaceutical Services Corp | 02/11/2015Terminated |
| Z-0953-2011 | The Stryker InterPulse system is a single patient use, sterile, disposable, pulsed…There is potential for a breach in sterility in the blister packaging. This can lead to the use of… | Stryker Instruments Division of Stryker… | 10/04/2010Terminated |
| Z-0952-2011 | The Stryker InterPulse system is a single patient use, sterile, disposable, pulsed…There is potential for a breach in sterility in the blister packaging. This can lead to the use of… | Stryker Instruments Division of Stryker… | 10/04/2010Terminated |
| Z-0951-2011 | The Stryker InterPulse system is a single patient use, sterile, disposable, pulsed…There is potential for a breach in sterility in the blister packaging. This can lead to the use of… | Stryker Instruments Division of Stryker… | 10/04/2010Terminated |
| Z-0950-2011 | The Stryker InterPulse system is a single patient use, sterile, disposable, pulsed…There is potential for a breach in sterility in the blister packaging. This can lead to the use of… | Stryker Instruments Division of Stryker… | 10/04/2010Terminated |
| Z-0949-2011 | The Stryker InterPulse system is a single patient use, sterile, disposable, pulsed…There is potential for a breach in sterility in the blister packaging. This can lead to the use of… | Stryker Instruments Division of Stryker… | 10/04/2010Terminated |
| Z-0948-2011 | The Stryker InterPulse system is a single patient use, sterile, disposable, pulsed…There is potential for a breach in sterility in the blister packaging. This can lead to the use of… | Stryker Instruments Division of Stryker… | 10/04/2010Terminated |
| Z-0947-2011 | The Stryker InterPulse system is a single patient use, sterile, disposable, pulsed…There is potential for a breach in sterility in the blister packaging. This can lead to the use of… | Stryker Instruments Division of Stryker… | 10/04/2010Terminated |
| Z-1698-2009 | Zimmer Pulsavac Wound Debridement System high capacity intramedullary brush tip…The seal on the sterile barrier pouch may be inadequate, resulting in lack of assurance of sterility. | Zimmer Inc. | 06/08/2009Terminated |
| Z-0865-2008 | Pulsavac Plus Low Pressure Fan Spray Kit, Catalog #00-5150-975-00, 10 kits/package…Sterility (package integrity) compromised; The effect of a silicone stain produced during assembly… | Zimmer Orthopaedic Surgical Products | 12/18/2007Terminated |
| Z-0864-2008 | Pulsavac Plus Wound Debridement System, Shower Spray Kit, Catalog #00-5150-495-00…Sterility (package integrity) compromised; The effect of a silicone stain produced during assembly… | Zimmer Orthopaedic Surgical Products | 12/18/2007Terminated |
| Z-0863-2008 | Pulsavac Plus AC Hip Kit, Catalog #00-5150-486-01, 1 kit/package, Zimmer Orthopaedic…Sterility (package integrity) compromised; The effect of a silicone stain produced during assembly… | Zimmer Orthopaedic Surgical Products | 12/18/2007Terminated |
| Z-0862-2008 | Pulsavac Hip Kit ,Catalog #00-5150-482-01, 1kit/package, Zimmer Orthopaedic Surgical…Sterility (package integrity) compromised; The effect of a silicone stain produced during assembly… | Zimmer Orthopaedic Surgical Products | 12/18/2007Terminated |
| Z-0861-2008 | Pulsavac Plus Wound Debridement System, Hip Kit, Catalog #00-5150-482-00, 10…Sterility (package integrity) compromised; The effect of a silicone stain produced during assembly… | Zimmer Orthopaedic Surgical Products | 12/18/2007Terminated |
| Z-0860-2008 | Pulsavac Plus AC Fan Spray Kit, Catalog #00-5150-476-01, 1 kit/package, Zimmer…Sterility (package integrity) compromised; The effect of a silicone stain produced during assembly… | Zimmer Orthopaedic Surgical Products | 12/18/2007Terminated |
| Z-0859-2008 | Pulsavac Fan Spray Kit ,Catalog #00-5150-475-01; 1kit/package, Zimmer Orthopaedic…Sterility (package integrity) compromised; The effect of a silicone stain produced during assembly… | Zimmer Orthopaedic Surgical Products | 12/18/2007Terminated |
| Z-0858-2008 | Pulsavac Plus Wound Debridement System, Fan Spray Kit , Catalog #00-5150-475-00, 10…Sterility (package integrity) compromised; The effect of a silicone stain produced during assembly… | Zimmer Orthopaedic Surgical Products | 12/18/2007Terminated |
| Z-0857-2008 | Pulsavac Plus AC Component Kit, Catalog #00-5150-426-01, 1 kit/package, Zimmer…Sterility (package integrity) compromised; The effect of a silicone stain produced during assembly… | Zimmer Orthopaedic Surgical Products | 12/18/2007Terminated |
| Z-0856-2008 | Pulsavac, Plus Wound Debridement System, Component Kit, Catalog # 00-5150-420-00,10…Sterility (package integrity) compromised; The effect of a silicone stain produced during assembly… | Zimmer Orthopaedic Surgical Products | 12/18/2007Terminated |
| Z-0715-2008 | Coloplast Elefant Suction/Irrigation Tubing, Part Number: AST 307, Coloplast Corp.…Lack of sterilization assurance: Sterilization of Elefant Suction-Irrigation Devices is not performed… | Coloplast Corp | 11/12/2007Terminated |
| Z-0714-2008 | Coloplast Elefant Suction/Irrigation Cannula for Laparoscopy with Tube, Part Numbers:…Lack of sterilization assurance: Sterilization of Elefant Suction-Irrigation Devices is not performed… | Coloplast Corp | 11/12/2007Terminated |
| Z-0713-2008 | Coloplast Elefant Suction/Irrigation Cannula for Laparoscopy Part Numbers: ASP 105, ASP…Lack of sterilization assurance: Sterilization of Elefant Suction-Irrigation Devices is not performed… | Coloplast Corp | 11/12/2007Terminated |