FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CONTAIN X-RAY DETECTABLE LAP SPONGE
K Number: K801768
·
Decision Aug 20, 1980
Classifications
1
FEI Numbers
211
Registration Numbers
211
Same Product Code
110
Applicant Total
18
Review Days
23
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Basic Information
- Device Name
- CONTAIN X-RAY DETECTABLE LAP SPONGE
- K Number
- K801768
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4450
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- The Buckeye Cellulose Corp.
- Date Received
- July 28, 1980
- Decision Date
- August 20, 1980
- 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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CPR LAP SPONGES
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STRYKER FEMORAL CANAL SPONGE & ACETABULUM SPONGE
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PROTEC X-RAY DETECTABLE GAUZE SPONGE
FDA 510(k)
FDA Class 1
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KENSORB
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
TRIANGULAR SPONGES
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by The Buckeye Cellulose Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K822925 | BOUNDARY SINGLE-USE GOWNS | Jan 12, 1983 | Substantially Equivalent |
| K823173 | ARRIRM SCRUB BRUSH/SPONGE | Nov 22, 1982 | Substantially Equivalent |
| K821564 | BOUNDARY PROCESS CHANGE | Jul 2, 1982 | Substantially Equivalent |
| K820758 | BOUNDARY SINGLE-USE CRANIOTOMY SHEET | Apr 29, 1982 | Substantially Equivalent |
| K820116 | BOUNDARY | Feb 23, 1982 | Substantially Equivalent |
| K813450 | BOUNDARY SINGLE-USE DRAPES | Jan 22, 1982 | Substantially Equivalent |
| K813390 | BONDARY SINGLE-USE OR GOWN | Jan 5, 1982 | Substantially Equivalent |
| K813277 | BOUNDARY DRAPE TAPE | Dec 18, 1981 | Substantially Equivalent |
| K813263 | PATIENT UNDERPAD | Nov 27, 1981 | Substantially Equivalent |
| K812962 | BOUNDARY SURGICAL DRAPE | Nov 20, 1981 | Substantially Equivalent |