FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
GREEN RADIOPAQUE IN SURG. SPONGES
K Number: K770924
·
Decision Aug 10, 1977
Classifications
1
FEI Numbers
211
Registration Numbers
211
Same Product Code
110
Applicant Total
14
Review Days
82
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Basic Information
- Device Name
- GREEN RADIOPAQUE IN SURG. SPONGES
- K Number
- K770924
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4450
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Kendall Research Center
- Date Received
- May 20, 1977
- Decision Date
- August 10, 1977
- 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
·General, Plastic Surgery
Other Clearances by Kendall Research Center
| K Number | Device Name | ||
|---|---|---|---|
| K802225 | TENDER-SORB DRAIN SPONGES | Sep 26, 1980 | Substantially Equivalent |
| K781357 | T.E.D. SEQUENTIAL COMPRESSION SLEEVES | Sep 20, 1978 | Substantially Equivalent |
| K780408 | MICRONET LIGHT DRESSING SPONGE | Mar 22, 1978 | Substantially Equivalent |
| K780062 | CATHETER/HEMOSTATIC/GERIATRIC | Feb 14, 1978 | Substantially Equivalent |
| K780120 | ANESTHESIA TRAY, CAUDAL | Feb 6, 1978 | Substantially Equivalent |
| K772134 | SYRINGE, IRRIGATION, PRE-FILLED | Nov 28, 1977 | Substantially Equivalent |
| K772133 | URINE SPECIMEN COLLECTING DEVICE | Nov 28, 1977 | Substantially Equivalent |
| K771655 | CURITY PEAKOMETER | Oct 14, 1977 | Substantially Equivalent |
| K771079 | CURITY IRRIGATION TRAY | Sep 15, 1977 | Substantially Equivalent |
| K771452 | CONFORM STRETCH BANDAGE (5SIZES) | Sep 12, 1977 | Substantially Equivalent |