BioBrace ® RC Delivery System
FDA 510(k) clearance K250395 · decided 2025-04-07
Clearance details
- K-number
- K250395
- Device name
- BioBrace ® RC Delivery System
- Applicant
- Conmed Corporation
- Decision
- Substantially Equivalent
- Date received
- 2025-02-12
- Decision date
- 2025-04-07
- Days to decision
- 54 days
- Clearance type
- Traditional
- Product code
- ORQ
- Device class
- 2
- Regulation number
- 878.3300
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Utica, NY, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ACCUMESH DEPLOYMENT SYSTEM (K130782) | Covidien, LLC | 2013-04-05 |
| ACCUMESH DEPLOYMENT SYSTEM (K123066) | Covidien, LLC | 2012-10-16 |
| ACCUMESH DEPLOYMENT SYSTEM (K121139) | Covidien, LLC | 2012-05-02 |
| PATCHASSIST LARGE (K103269) | Polytouch Medical, Ltd. | 2010-11-23 |
| PATCHASSIST (K101218) | Polytouch Medical, Ltd. | 2010-06-17 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| ConMed PadPro Multifunction Electrodes (P200004/S001) | Conmed Corporation | 2022-06-16 |
| ConMed PadPro Multifunction Electrodes, ConMed PadPro Multifunction Electrode Adapters (P200004) | Conmed Corporation | 2021-09-26 |