K253996 is an FDA 510(k) clearance for the BD Surgiphor™ Antimicrobial Irrigation System (910110). This device is classified as a Lavage, Jet (Class II - Special Controls, product code FQH).
Submitted by Becton, Dickinson and Company (BD) (Vernon Hills, US). The FDA issued a Cleared decision on February 25, 2026, 75 days after receiving the submission on December 12, 2025.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 880.5475.
| 510(k) Number | K253996 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 12, 2025 |
| Decision Date | February 25, 2026 |
| Days to Decision | 75 days |
| Submission Type | Special |
| 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 |