FQH — Lavage, Jet Class II
FDA product code FQH covers "Lavage, Jet", a Class II medical device regulated under 21 CFR 880.5475. Submissions are reviewed by the General Hospital panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- FQH
- Device Class
- Class II
- Regulation Number
- 880.5475
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253996 | becton, dickinson and company (bd) | BD Surgiphor Antimicrobial Irrigation System (910110) | February 25, 2026 |
| K253445 | bd | BD Surgiphor 1000 mL Antimicrobial Irrigation System (910120) | February 20, 2026 |
| K231023 | erbe elektromedizin | ERBEJET® 2 System | June 15, 2023 |
| K220759 | armis biopharma | Armis VeriCyn Wound Wash | May 25, 2023 |
| K220964 | smith and nephew medical limited | VERSAJET Hydrosurgery System (III) | May 16, 2023 |
| K221504 | bd | BD Surgiphor Antimicrobial Irrigation System | October 14, 2022 |
| K222804 | irrimax corporation | Irrisept Antimicrobial Wound Lavage | September 22, 2022 |
| K210987 | inopro | IRRIGO Wound Wash Jet System | May 31, 2022 |
| K213616 | becton, dickinson and | BD Surgiphor Antimicrobial Irrigation System | March 23, 2022 |
| K210536 | irrimax corporation | Irrisept Antimicrobial Wound Lavage | May 28, 2021 |
| K202222 | irrimax corporation | Irrisept Wound Debridement and Cleansing System | December 14, 2020 |
| K202071 | orthophor | SURGIPHOR Wound Irrigation System | October 23, 2020 |
| K192349 | next science | Bactisure Wound Lavage | January 23, 2020 |
| K161165 | next science | Next Science Irrigation Solution | September 7, 2016 |
| K143115 | smith and nephew | The VersaJet II Hydrosurgery System | July 15, 2015 |
| K113312 | patrin pharma | HY-CHLO(TM)WOUND SCRUB | August 21, 2012 |
| K111313 | alcavis hdc | EXSEPT SKIN AND WOUND CLEANSER WITH ANTIMICROBIAL PRESERVATIVE | December 14, 2011 |
| K110958 | smith and nephew | VERSAJET II HYDROSURGERY SYSTEM CONSOLE / EXACT HANDPIECES / PLUS HANDPIECES, VE | August 1, 2011 |
| K090848 | premier brands of america | PREMIER STERILE SALINE WOUND WASH, MODELS 210 ML, WWM | June 17, 2009 |
| K082858 | alcavis international | EXSEPT WC ANTIMICROBIAL SKIN AND WOUND CLEANSER | May 27, 2009 |