SURGICAL TISSUE POUCH
FDA 510(k) clearance K910914 · decided 1991-03-28
Clearance details
- K-number
- K910914
- Device name
- SURGICAL TISSUE POUCH
- Applicant
- Cook Urological, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-03-05
- Decision date
- 1991-03-28
- Days to decision
- 23 days
- Clearance type
- Traditional
- Product code
- KGY
- Device class
- 1
- Regulation number
- 878.4100
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Spencer, IN, US
- Third-party review
- No
- Expedited review
- No
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Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| GOODMAN BANDAGE (K933085) | Megadyne Medical Products, Inc. | 1993-12-23 |
| TROCAR CATHETER (K913678) | Medovations, Inc. | 1991-12-16 |
| ISOLATION BAG 3M (K832318) | 3M Company | 1983-10-31 |
| BAND-AID BRAND TRICOT MESH BANDAGES (K801823) | Johnson & Johnson Professionals, Inc. | 1980-08-20 |
| BAND-AID BRAND FLEXIBLE FABRIC BANDAGE (K801824) | Johnson & Johnson Professionals, Inc. | 1980-08-20 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| LapSac Surgical Tissue Pouch. The current intended use for the LapSac Surgical Tissue Pouc recall (Z-1830-2015) | Cook Inc. | 2015-06-24 |