DIAPHRAGMATIC HERNIA GRAFT
FDA 510(k) clearance K133011 · decided 2014-06-20
Clearance details
- K-number
- K133011
- Device name
- DIAPHRAGMATIC HERNIA GRAFT
- Applicant
- Cook Biotech, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2013-09-25
- Decision date
- 2014-06-20
- Days to decision
- 268 days
- Clearance type
- Traditional
- Product code
- OWV
- 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.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Cook Medical Biodesign Hiatal Hernia Graft, REF C-PHR-7X10-U, REF G31455, Sterile; and recall (Z-0833-2025) | Cook Biotech, Inc. | 2025-01-10 |