510(k) K250395
- Device
- BioBrace ® RC Delivery System
- Applicant
- Conmed Corporation
- 510(k) number
- K250395
- Product code
- ORQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-04-07
- Date received
- 2025-02-12
- Regulation
- 878.3300
- Classification name
- Mesh, Surgical, Deployer
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Dionne Sanders
- Address
- 525 French Rd. Utica NY US 13502 13502
FDA Registration Numbers#
- 3003604053
- 3012358417
- 3006082230
- 2246552
- 3010273872
- 3016678045
- 3027448274
- 1219930
- 3021632375
- 1213643
- 3013188547
- 3005636544
- 2249852
- 1017294
- 3018094310
Source Documents#
Other 510(k) Records For Product Code ORQ#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K130782 | ACCUMESH DEPLOYMENT SYSTEM | Covidien, LLC | 2013-04-05 |
| K123066 | ACCUMESH DEPLOYMENT SYSTEM | Covidien, LLC | 2012-10-16 |
| K121139 | ACCUMESH DEPLOYMENT SYSTEM | Covidien, LLC | 2012-05-02 |
| K103269 | PATCHASSIST LARGE | Polytouch Medical, Ltd. | 2010-11-23 |
| K101218 | PATCHASSIST | Polytouch Medical, Ltd. | 2010-06-17 |