FQH · Lavage, Jet
General Hospital · 21 CFR 880.5475 · Class 2
Overview
| Product Code | FQH |
|---|---|
| Device Name | Lavage, Jet |
| Regulation | 21 CFR 880.5475 |
| Device Class | Class 2 |
| Review Panel | General Hospital |
Identification
A jet lavage is a device used to clean a wound by a pulsatile jet of sterile fluid. The device consists of the pulsing head, tubing to connect to a container of sterile fluid, and a means of propelling the fluid through the tubing, such as an electric roller pump.
Classification Rationale
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.
Recent Cleared Devices (20 of 53)
Showing 20 most recent of 53 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K253996 | BD Surgiphor Antimicrobial Irrigation System (910110) | Becton, Dickinson and Company (BD) | Feb 25, 2026 | SESE |
| K253445 | BD Surgiphor 1000 mL Antimicrobial Irrigation System (910120) | Bd | Feb 20, 2026 | SESE |
| K231023 | ERBEJET® 2 System | Erbe Elektromedizin GmbH | Jun 15, 2023 | SESE |
| K220759 | Armis VeriCyn Wound Wash | Armis Biopharma, Inc. | May 25, 2023 | SESE |
| K220964 | VERSAJET Hydrosurgery System (III) | Smith & Nephew Medical Limited | May 16, 2023 | SESE |
| K221504 | BD Surgiphor Antimicrobial Irrigation System | Bd | Oct 14, 2022 | SESE |
| K222804 | Irrisept Antimicrobial Wound Lavage | Irrimax Corporation | Sep 22, 2022 | SESE |
| K210987 | IRRIGO Wound Wash Jet System | Inopro, Inc. | May 31, 2022 | SESE |
| K213616 | BD Surgiphor Antimicrobial Irrigation System | Becton, Dickinson and Company | Mar 23, 2022 | SESE |
| K210536 | Irrisept Antimicrobial Wound Lavage | Irrimax Corporation | May 28, 2021 | SESE |
| K202222 | Irrisept Wound Debridement and Cleansing System | Irrimax Corporation | Dec 14, 2020 | SESE |
| K202071 | SURGIPHOR Wound Irrigation System | Orthophor, LLC | Oct 23, 2020 | SESE |
| K192349 | Bactisure Wound Lavage | Next Science, LLC | Jan 23, 2020 | SESE |
| K161165 | Next Science Irrigation Solution | Next Science, LLC | Sep 7, 2016 | SESE |
| K143115 | The VersaJet II Hydrosurgery System | Smith & Nephew, Inc. | Jul 15, 2015 | SESE |
| K113312 | HY-CHLO(TM)WOUND SCRUB | Patrin Pharma | Aug 21, 2012 | SESE |
| K111313 | EXSEPT SKIN AND WOUND CLEANSER WITH ANTIMICROBIAL PRESERVATIVE | Alcavis Hdc, LLC | Dec 14, 2011 | SESE |
| K110958 | VERSAJET II HYDROSURGERY SYSTEM CONSOLE / EXACT HANDPIECES / PLUS HANDPIECES, VERSAJET FOOTSWITCH | Smith & Nephew, Inc. | Aug 1, 2011 | SESE |
| K090848 | PREMIER STERILE SALINE WOUND WASH, MODELS 210 ML, WWM | Premier Brands of America, Inc. | Jun 17, 2009 | SESE |
| K082858 | EXSEPT WC ANTIMICROBIAL SKIN AND WOUND CLEANSER | Alcavis International, Inc. | May 27, 2009 | SESE |
Top Applicants
- Irrimax Corporation — 4 clearances
- Erbe USA, Inc. — 3 clearances
- Hydrocision, Inc. — 3 clearances
- Bd — 2 clearances
- Howmedica Corp. — 2 clearances
