K253445 is an FDA 510(k) clearance for the BD Surgiphor™ 1000 mL Antimicrobial Irrigation System (910120). This device is classified as a Lavage, Jet (Class II - Special Controls, product code FQH).
Submitted by Bd (Vernon Hills, US). The FDA issued a Cleared decision on February 20, 2026, 141 days after receiving the submission on October 2, 2025.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 880.5475.
| 510(k) Number | K253445 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 02, 2025 |
| Decision Date | February 20, 2026 |
| Days to Decision | 141 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 |