BIODESIGN SURGISIS ANTERIOR POSTERIOR PELVIC FLOOR GRAFTS
FDA 510(k) clearance K130006 · decided 2013-04-05
Clearance details
- K-number
- K130006
- Device name
- BIODESIGN SURGISIS ANTERIOR POSTERIOR PELVIC FLOOR GRAFTS
- Applicant
- Cook Biotech Incorporated
- Decision
- Substantially Equivalent
- Date received
- 2013-01-02
- Decision date
- 2013-04-05
- Days to decision
- 93 days
- Clearance type
- Traditional
- Product code
- PAI
- Device class
- 3
- Regulation number
- 884.5980
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- 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 |
|---|---|---|
| PERMACOL SURGICAL IMPLANT T-PIECE, PERMACOL SURGICAL IMPLANT RECTOCELE-PIECE, MODELS 5928-150, 5645-150 (K050355) | Tissue Science Laboratories, Plc | 2005-03-09 |
Recalls involving this device
No recalls on record reference this clearance.