STRATASIS SLING KIT
FDA 510(k) clearance K020654 · decided 2002-04-09
Clearance details
- K-number
- K020654
- Device name
- STRATASIS SLING KIT
- Applicant
- Cook Biotech, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-02-28
- Decision date
- 2002-04-09
- Days to decision
- 40 days
- Clearance type
- Traditional
- Product code
- PAG
- 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 |
|---|---|---|
| COOK UROLOGICAL GRAFT (K090688) | Cook Biotech, Inc. | 2009-07-10 |
| AMS COLLAGEN DERMAL MATRIX (K050445) | American Medical Systems, Inc. | 2005-06-17 |
| PELVILACE TRANSOBTURATOR BIOURETHRAL SUPPORT SYSTEM (PELVILACE TO SYSTEM) (K042949) | C.R. Bard, Inc. | 2004-11-09 |
| BARD INNERLACE BIOURETHRAL SUPPORT SYSTEM (K031295) | C.R. Bard, Inc. | 2003-05-15 |
| MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX (K030460) | Brennen Medical, Inc. | 2003-03-07 |
| MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX (K993459) | Advanced Uroscience, Inc. | 1999-11-05 |
| SURGISIS SLING (K992159) | Cook Biotech, Inc. | 1999-09-23 |
| BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX (K982403) | Brennen Medical, Inc. | 1998-09-22 |
Recalls involving this device
No recalls on record reference this clearance.