SURGISIS STAPLE LINE REINFORCEMENT
FDA 510(k) clearance K022044 · decided 2002-08-23
Clearance details
- K-number
- K022044
- Device name
- SURGISIS STAPLE LINE REINFORCEMENT
- Applicant
- Cook Biotech, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-06-24
- Decision date
- 2002-08-23
- Days to decision
- 60 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
- West Lafayette, IN, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Cook Biotech
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Biodesign Staple Line Reinforcement (K170945) | Cook Biotech Incorporated | 2017-04-28 |
| Kerecis SecureMesh (K153364) | Kerecis Limited | 2016-08-19 |
| VERITAS COLLAGEN MATRIX (K030879) | Synovis Surgical Innovations | 2003-04-24 |
Recalls involving this device
No recalls on record reference this clearance.