K213616 is an FDA 510(k) clearance for the BD Surgiphor Antimicrobial Irrigation System. This device is classified as a Lavage, Jet (Class II - Special Controls, product code FQH).
Submitted by Becton, Dickinson and Company (Vernon Hills, US). The FDA issued a Cleared decision on March 23, 2022, 128 days after receiving the submission on November 15, 2021.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 880.5475.
| 510(k) Number | K213616 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 15, 2021 |
| Decision Date | March 23, 2022 |
| Days to Decision | 128 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FQH — Lavage, Jet |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5475 |