K250098 is an FDA 510(k) clearance for the Bard Soft Mesh; Bard Soft Mesh Pre-Shaped, a Mesh, Surgical, Polymeric (Class II — Special Controls, product code FTL), submitted by Davol, Inc. (Warwick, US). The FDA issued a Cleared decision on April 9, 2025, 85 days after receiving the submission on January 14, 2025. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.3300.
| 510(k) Number | K250098 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 14, 2025 |
| Decision Date | April 09, 2025 |
| Days to Decision | 85 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FTL — Mesh, Surgical, Polymeric |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.3300 |