Product code FQH
- Device name
- Lavage, Jet
- Medical specialty
- General Hospital
- Device class
- 2
- Regulation number
- 880.5475
- Review panel
- HO
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253996 | BD Surgiphor™ Antimicrobial Irrigation System (910110) | Becton, Dickinson and Company (BD) | 2026-02-25 |
| K253445 | BD Surgiphor™ 1000 mL Antimicrobial Irrigation System (910120) | Bd | 2026-02-20 |
| K231023 | ERBEJET® 2 System | Erbe Elektromedizin GmbH | 2023-06-15 |
| K220759 | Armis VeriCyn Wound Wash | Armis Biopharma, Inc. | 2023-05-25 |
| K220964 | VERSAJET Hydrosurgery System (III) | Smith & Nephew Medical Limited | 2023-05-16 |
| K221504 | BD Surgiphor™ Antimicrobial Irrigation System | Bd | 2022-10-14 |
| K222804 | Irrisept Antimicrobial Wound Lavage | Irrimax Corporation | 2022-09-22 |
| K210987 | IRRIGO Wound Wash Jet System | Inopro, Inc. | 2022-05-31 |
| K213616 | BD Surgiphor Antimicrobial Irrigation System | Becton, Dickinson and Company | 2022-03-23 |
| K210536 | Irrisept Antimicrobial Wound Lavage | Irrimax Corporation | 2021-05-28 |
| K202222 | Irrisept Wound Debridement and Cleansing System | Irrimax Corporation | 2020-12-14 |
| K202071 | SURGIPHOR Wound Irrigation System | Orthophor, LLC | 2020-10-23 |
| K192349 | Bactisure Wound Lavage | Next Science, LLC | 2020-01-23 |
| K161165 | Next Science Irrigation Solution | Next Science, LLC | 2016-09-07 |
| K143115 | The VersaJet II Hydrosurgery System | Smith & Nephew, Inc. | 2015-07-15 |
| K113312 | HY-CHLO(TM)WOUND SCRUB | Patrin Pharma | 2012-08-21 |
| K111313 | EXSEPT SKIN AND WOUND CLEANSER WITH ANTIMICROBIAL PRESERVATIVE | Alcavis Hdc, LLC | 2011-12-14 |
| K110958 | VERSAJET II HYDROSURGERY SYSTEM CONSOLE / EXACT HANDPIECES / PLUS HANDPIECES, VERSAJET FOOTSWITCH | Smith & Nephew, Inc. | 2011-08-01 |
| K090848 | PREMIER STERILE SALINE WOUND WASH, MODELS 210 ML, WWM | Premier Brands of America, Inc. | 2009-06-17 |
| K082858 | EXSEPT WC ANTIMICROBIAL SKIN AND WOUND CLEANSER | Alcavis International, Inc. | 2009-05-27 |
| K080779 | IRRISEPT WOUND CLEANSING SYSTEM | Irrimax Corporation | 2009-02-04 |
| K072404 | ERBE ERBEJET 2 SYSTEM | Erbe USA, Inc. | 2007-10-31 |
| K060782 | VERSAJET HYDROSURGERY SYSTEM AND HANDPIECE | Smith & Nephew Wound Management | 2006-04-12 |
| K033590 | ERBE HELIX HYDRO-JET | Erbe USA, Inc. | 2004-01-30 |
| K021813 | HYDROCISION GENERAL SURGERY FLUIDJET SYSTEM | Hydrocision, Inc. | 2003-05-09 |
| K022613 | HELIX HYDRO-JET | Erbe USA, Inc. | 2002-10-25 |
| K012464 | HELIX HYDRO-JET | Andreas Pein Medizintechnik GmbH | 2001-10-10 |
| K011612 | MODIFICATION TO HYDROCISION DEBRIDEMENT SYSTEM | Hydrocision, Inc. | 2001-06-22 |
| K991383 | HYDROCISION DEBDRIDEMENT SYSTEM | Hydrocision, Inc. | 2000-03-31 |
| K983135 | BLOWER/MISTER | Cardiothoracic Systems, Inc. | 1998-11-13 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 05051471221512 | De Soutter Medical | DE SOUTTER MEDICAL LIMITED | 2026-05-27 |
| 07649996166302 | debritom+ | Medaxis AG | 2026-04-17 |
| 07640407460811 | debritom+ | Medaxis AG | 2026-04-17 |
| 07649996166043 | debritom+ | Medaxis AG | 2026-04-08 |
| 10842351120047 | Irrisept Antimicrobial Wound Lavage | IRRIMAX CORPORATION | 2024-07-16 |
| 10842351180010 | Irrisept Wound Solution Kit | IRRIMAX CORPORATION | 2024-07-01 |
| 10842351120030 | Irrisept Antimicrobial Wound Lavage - 150 ml sterile | IRRIMAX CORPORATION | 2023-04-20 |
| 10842351120023 | Irrisept Rapid Packaging - 150 ml non sterile-Rapid Packaging | IRRIMAX CORPORATION | 2023-04-20 |
| 10842351120016 | Irrisept Antimicrobial Wound Lavage | IRRIMAX CORPORATION | 2022-12-17 |
| 10842351120009 | Irrisept Antimicrobial Wound Lavage | IRRIMAX CORPORATION | 2022-10-21 |
| 10842351110093 | Irrisept Antimicrobial Wound Lavage | IRRIMAX CORPORATION | 2022-10-21 |
| 07649996166050 | debritom+ | Medaxis AG | 2021-09-09 |
| 07649996166159 | debritom+ | Medaxis AG | 2021-09-09 |
| 07649996166135 | debritom+ | Medaxis AG | 2021-09-09 |
| 07649996166111 | debritom+ | Medaxis AG | 2021-09-09 |
| 07649996166098 | debritom+ | Medaxis AG | 2021-09-09 |
| 07649996166074 | debritom+ | Medaxis AG | 2021-09-09 |
| 10193489381917 | Medline Industries, Inc. | MEDLINE INDUSTRIES, INC. | 2021-08-27 |
| 07613327351002 | Interpulse | STRYKER CORPORATION | 2016-10-27 |
| 07613327003925 | InterPulse | STRYKER CORPORATION | 2016-09-23 |
| 07613327003918 | InterPulse | STRYKER CORPORATION | 2016-09-23 |
| 07613154730216 | InterPulse | STRYKER CORPORATION | 2016-09-23 |
| 07613154547258 | InterPulse | STRYKER CORPORATION | 2016-09-23 |
| 07613154476084 | InterPulse | STRYKER CORPORATION | 2016-09-23 |
| 07613154076864 | InterPulse | STRYKER CORPORATION | 2016-09-23 |
| 07613154054084 | InterPulse | STRYKER CORPORATION | 2016-09-23 |
| 07613153097945 | NA | STRYKER CORPORATION | 2016-09-23 |
| 07613153088530 | NA | STRYKER CORPORATION | 2016-09-23 |
| 07613153088516 | NA | STRYKER CORPORATION | 2016-09-23 |
| 07613153088486 | NA | STRYKER CORPORATION | 2016-09-23 |