Kerecis SecureMesh
FDA 510(k) clearance K153364 · decided 2016-08-19
Clearance details
- K-number
- K153364
- Device name
- Kerecis SecureMesh
- Applicant
- Kerecis Limited
- Decision
- Substantially Equivalent
- Date received
- 2015-11-20
- Decision date
- 2016-08-19
- Days to decision
- 273 days
- Clearance type
- Traditional
- Product code
- OXE
- Device class
- 2
- Regulation number
- 878.3300
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Isafjordur, IS
- Third-party review
- No
- Expedited review
- No
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| Biodesign Staple Line Reinforcement (K170945) | Cook Biotech Incorporated | 2017-04-28 |
| VERITAS COLLAGEN MATRIX (K030879) | Synovis Surgical Innovations | 2003-04-24 |
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Recalls involving this device
No recalls on record reference this clearance.