K250395 is an FDA 510(k) clearance for the BioBrace ? RC Delivery System. This device is classified as a Mesh, Surgical, Deployer (Class II - Special Controls, product code ORQ).
Submitted by Conmed Corporation (Utica, US). The FDA issued a Cleared decision on April 7, 2025, 54 days after receiving the submission on February 12, 2025.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 878.3300. Intended To Be Used To Facilitate The Delivery Of Soft Tissue Prosthetics During The Laparoscopic Repair Of Soft Tissue Defects (e.g. Hernia Repair)..
| 510(k) Number | K250395 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 12, 2025 |
| Decision Date | April 07, 2025 |
| Days to Decision | 54 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | ORQ — Mesh, Surgical, Deployer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.3300 |
| Definition | Intended To Be Used To Facilitate The Delivery Of Soft Tissue Prosthetics During The Laparoscopic Repair Of Soft Tissue Defects (e.g. Hernia Repair). |