Biodesign Staple Line Reinforcement
FDA 510(k) clearance K170945 · decided 2017-04-28
Clearance details
- K-number
- K170945
- Device name
- Biodesign Staple Line Reinforcement
- Applicant
- Cook Biotech Incorporated
- Decision
- Substantially Equivalent
- Date received
- 2017-03-30
- Decision date
- 2017-04-28
- Days to decision
- 29 days
- Clearance type
- Special
- Product code
- OXE
- Device class
- 2
- Regulation number
- 878.3300
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- West Lafayette, IN, 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 |
|---|---|---|
| Kerecis SecureMesh (K153364) | Kerecis Limited | 2016-08-19 |
| VERITAS COLLAGEN MATRIX (K030879) | Synovis Surgical Innovations | 2003-04-24 |
| SURGISIS STAPLE LINE REINFORCEMENT (K022044) | Cook Biotech, Inc. | 2002-08-23 |
Recalls involving this device
No recalls on record reference this clearance.