BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX
FDA 510(k) clearance K982403 · decided 1998-09-22
Clearance details
- K-number
- K982403
- Device name
- BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX
- Applicant
- Brennen Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-07-10
- Decision date
- 1998-09-22
- Days to decision
- 74 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
- St. Paul, MN, 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 |
| STRATASIS SLING KIT (K020654) | Cook Biotech, Inc. | 2002-04-09 |
| MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX (K993459) | Advanced Uroscience, Inc. | 1999-11-05 |
| SURGISIS SLING (K992159) | Cook Biotech, Inc. | 1999-09-23 |
Recalls involving this device
No recalls on record reference this clearance.