FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SPECIALTY SPONGES
K Number: K935881
·
Decision Jan 31, 1994
Classifications
1
FEI Numbers
211
Registration Numbers
211
Same Product Code
110
Applicant Total
19
Review Days
53
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Basic Information
- Device Name
- SPECIALTY SPONGES
- K Number
- K935881
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4450
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Mcneil Healthcare, Inc.
- Date Received
- December 9, 1993
- Decision Date
- January 31, 1994
- 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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KENSORB
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Other Clearances by Mcneil Healthcare, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K935883 | NEUROLOGICAL SPONGES | Feb 3, 1994 | Substantially Equivalent |
| K935930 | NON ADHERENT DRESSING AND NON ADHERENT DRAIN DRESSING | Feb 3, 1994 | Substantially Equivalent |
| K935993 | SURGICAL SPONGE X-RAY DETECTABLE | Feb 2, 1994 | Substantially Equivalent |
| K935934 | NON ADHERANT BURN PADS | Jan 31, 1994 | Substantially Equivalent |
| K935910 | X-RAY PACKING SPONGE | Jan 31, 1994 | Substantially Equivalent |
| K935911 | PACKING SPONGE | Jan 31, 1994 | Substantially Equivalent |
| K935882 | TONSIL SPONGES | Jan 31, 1994 | Substantially Equivalent |
| K935933 | CUSTOM BURN DRESSING | Jan 14, 1994 | Substantially Equivalent |
| K935936 | CONFORMING ROLL | Jan 14, 1994 | Substantially Equivalent |
| K935937 | POST OP SPONGE | Jan 14, 1994 | Substantially Equivalent |