DYNAREX TRACHEOSTOMY SPONGE
FDA 510(k) clearance K983348 · decided 1998-12-11
Clearance details
- K-number
- K983348
- Device name
- DYNAREX TRACHEOSTOMY SPONGE
- Applicant
- Dynarex Corp.
- Decision
- Substantially Equivalent
- Date received
- 1998-09-23
- Decision date
- 1998-12-11
- Days to decision
- 79 days
- Clearance type
- Traditional
- Product code
- EFQ
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Brewster, NY, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Dynarex Corp.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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 |
| 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 |
| KENDALL CURITY IODOFORM PACKING STRIP (K973763) | Kendall Healthcare Products Co. Div.Of Tyco Health | 1997-12-31 |
Recalls involving this device
No recalls on record reference this clearance.