K253445 is an FDA 510(k) clearance for the BD Surgiphor? 1000 mL Antimicrobial Irrigation System (910120), 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 review panel. Regulated under 21 CFR 880.5475.
| 510(k) Number | K253445 FDA.gov |
| FDA Decision | Cleared 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 |