FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
NON-WOVEN TRACHEOTOMY SPONGE
K Number: K872807
·
Decision Aug 4, 1987
Classifications
1
FEI Numbers
228
Registration Numbers
228
Same Product Code
111
Applicant Total
14
Review Days
21
Basic Information
- Device Name
- NON-WOVEN TRACHEOTOMY SPONGE
- K Number
- K872807
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4450
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- AMERICAN SILK SUTURES, INC.
- Date Received
- July 14, 1987
- Decision Date
- August 4, 1987
- 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
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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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Other Clearances by AMERICAN SILK SUTURES, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K922143 | AMERICAN BURN SHEET | Aug 10, 1992 | Substantially Equivalent |
| K904514 | STRUNG TELFA NON-ADHERENT SPONGE | Mar 27, 1991 | Substantially Equivalent |
| K902921 | RAYON NEUROLOGICAL SPONGE | Sep 18, 1990 | Substantially Equivalent |
| K872810 | STRUNG DENTAL ROLLS | Dec 4, 1987 | Substantially Equivalent |
| K872951 | AMERICAN BRAIN RETRACTOR COVER | Sep 16, 1987 | Substantially Equivalent |
| K872905 | AMERICAN NASAL SPONGE | Sep 4, 1987 | Substantially Equivalent |
| K872906 | SUCTION TUBE TIP FITS OVER BUSSIE FRAZIER TUBE | Aug 11, 1987 | Substantially Equivalent |
| K872808 | CHEVRON TAPE DISSECTOR, 9/16 X 1/4, 9/16 X 1/8 | Aug 4, 1987 | Substantially Equivalent |
| K872806 | STICK SPONGE, STRUNG TONSIL SPONGE DOUBLE STRUNG | Aug 4, 1987 | Substantially Equivalent |
| K872809 | GAUZE CHERRY SPONGE | Aug 4, 1987 | Substantially Equivalent |