FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ZANLEX, ZAN-TEX & ZANDEX
K Number: K830511
·
Decision Mar 17, 1983
Classifications
1
FEI Numbers
211
Registration Numbers
211
Same Product Code
110
Applicant Total
11
Review Days
28
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Basic Information
- Device Name
- ZANLEX, ZAN-TEX & ZANDEX
- K Number
- K830511
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4450
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Winn Hirsch & Assoc.
- Date Received
- February 17, 1983
- Decision Date
- March 17, 1983
- Product Code
- GDY
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| GDY | Gauze/Sponge, Internal, X-Ray Detectable | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GDY), ordered by most recent decision date.
ULTRACELL SUCTION SPONGE
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STRYKER FEMORAL CANAL SPONGE & ACETABULUM SPONGE
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PROTEC X-RAY DETECTABLE GAUZE SPONGE
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KENSORB
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TRIANGULAR SPONGES
FDA 510(k)
FDA Class 1
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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 |
| K832213 | GAUZE CONVERSION CLASS II STERILE | Jul 26, 1983 | Substantially Equivalent |
| K832214 | GAUZE CONVERSION CLASS I-NON-STERILE | Jul 26, 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 |