GAUZE SWABS, NON-STERILE
FDA 510(k) clearance K885142 · decided 1989-01-24
Clearance details
- K-number
- K885142
- Device name
- GAUZE SWABS, NON-STERILE
- Applicant
- Smith & Nephew, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1988-12-15
- Decision date
- 1989-01-24
- Days to decision
- 40 days
- Clearance type
- Traditional
- Product code
- EFQ
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Miami, FL, 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 |
|---|---|---|
| NON-ABSORBABLE GAUZE FOR EXTERNAL USE, STERILE AND NON STERILE (K991757) | Furlong Industries | 1999-08-12 |
| SYMTEX GAUZE PADS (1'S) AND SYMTEX GAUZE SPONGES STERILE 2'S AND STERILE 10'S (K991215) | Symtex Healthcare Corp. | 1999-06-11 |
| VITOP DRESSING (K990974) | Wonder & Bioenergy Hi-Tech America, Inc. | 1999-06-09 |
| GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLE (K990584) | Broadline Medical Industries | 1999-04-23 |
| CROSSTEX NON-WOVEN SPONGES (K984187) | Crosstex Intl. | 1999-02-18 |
| GAUZE, SPONGES, CAT # 11-003 (K983016) | Vitalcare Group, Inc. | 1999-02-12 |
| DYNAREX TRACHEOSTOMY SPONGE (K983348) | Dynarex Corp. | 1998-12-11 |
| STARRYSHINE GAUZE SPONGE (K983450) | T.C. Dental Products, Inc. | 1998-11-12 |
| JOAN II (K982648) | Celanese Acetate Co. | 1998-09-30 |
| DUMEX PAK-ITS WOVEN RIBBON PACKING (K980791) | Dumex Medical Surgical Products, Ltd. | 1998-04-29 |
| HYDROFERA FEMORAL WICK (K974316) | Hydrofera, LLC | 1998-02-13 |
| BALDUR NON-STERILE COTTON SPONGES (K974347) | Baldur Systems Corp. | 1998-02-10 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Ascension MCP (P000057/S013) | Smith & Nephew, Inc. | 2025-12-31 |
| ASCENSION MCP (P000057/S014) | Smith & Nephew, Inc. | 2025-08-05 |
| R3 Delta Ceramic Acetabular System (P150030/S049) | Smith & Nephew, Inc. | 2025-04-17 |
| R3 DELTA CERAMIC HIP SYSTEM (P150030/S048) | Smith & Nephew, Inc. | 2025-03-03 |
| R3 Delta Ceramic Hip System (P150030/S045) | Smith & Nephew, Inc. | 2025-02-28 |
| R3 Delta Ceramic Acetabular System (P150030/S047) | Smith & Nephew, Inc. | 2025-02-21 |
| R3 Delta Ceramic Acetabular System (P150030/S046) | Smith & Nephew, Inc. | 2025-01-16 |
| BIRMINGHAM HIP RESURFACING (BHR) SYSTEM (P040033/S039) | Smith & Nephew, Inc. | 2025-01-10 |