FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
GAUZE CONVERSION CLASS II STERILE
K Number: K832213
·
Decision Jul 26, 1983
Classifications
1
FEI Numbers
59
Registration Numbers
59
Same Product Code
270
Applicant Total
11
Review Days
14
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Basic Information
- Device Name
- GAUZE CONVERSION CLASS II STERILE
- K Number
- K832213
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Applicant
- Winn Hirsch & Assoc.
- Date Received
- July 12, 1983
- Decision Date
- July 26, 1983
- Product Code
- EFQ
- Advisory Committee
- Unknown
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| EFQ | Gauze/Sponge, Internal | FDA unclassified | Unknown |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EFQ), ordered by most recent decision date.
NON-ABSORBABLE GAUZE FOR EXTERNAL USE, STERILE AND NON STERILE
FDA 510(k)
FDA Unclassified
·Unknown
SYMTEX GAUZE PADS (1'S) AND SYMTEX GAUZE SPONGES STERILE 2'S AND STERILE 10'S
FDA 510(k)
FDA Unclassified
·Unknown
VITOP DRESSING
FDA 510(k)
FDA Unclassified
·Unknown
GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLE
FDA 510(k)
FDA Unclassified
·Unknown
CROSSTEX NON-WOVEN SPONGES
FDA 510(k)
FDA Unclassified
·Unknown
GAUZE, SPONGES, CAT # 11-003
FDA 510(k)
FDA Unclassified
·Unknown
Other Clearances by Winn Hirsch & Assoc.
| K Number | Device Name | ||
|---|---|---|---|
| K880309 | TYPE 316L STAINLESS STEEL WIRE | Feb 29, 1988 | Substantially Equivalent |
| K864375 | TYPE 316L COTTER WIRE | May 20, 1987 | Substantially Equivalent for Some Indications |
| K832214 | GAUZE CONVERSION CLASS I-NON-STERILE | Jul 26, 1983 | Substantially Equivalent |
| K830511 | ZANLEX, ZAN-TEX & ZANDEX | Mar 17, 1983 | Substantially Equivalent |
| K812391 | NEUROSPONGES | Nov 24, 1981 | Substantially Equivalent |
| K812390 | NEUROSPONGE PADDIE | Nov 24, 1981 | Substantially Equivalent |
| K800195 | COTTON UNDER CAST PADDING | Feb 11, 1980 | Substantially Equivalent |
| K761155 | CELLULOSE EYE STICK | Dec 16, 1976 | Substantially Equivalent |
| K760513 | ELECTRODE, TEMPORARY MYOCARDIAL | Oct 15, 1976 | Substantially Equivalent |
| K760365 | BLANKET, BURN | Aug 11, 1976 | Substantially Equivalent |