FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
GAUZE SPONGES
K Number: K944879
·
Decision Dec 23, 1994
Classifications
1
FEI Numbers
211
Registration Numbers
211
Same Product Code
110
Applicant Total
14
Review Days
81
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Basic Information
- Device Name
- GAUZE SPONGES
- K Number
- K944879
- 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
- Clinical Resources, Inc.
- Date Received
- October 3, 1994
- Decision Date
- December 23, 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
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
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KENSORB
FDA 510(k)
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TRIANGULAR SPONGES
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by Clinical Resources, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K941470 | TRACHEOSTOMY CARE KIT | Feb 14, 1995 | Unknown |
| K944882 | IRRIGATION TRAY | Jan 12, 1995 | Substantially Equivalent |
| K944881 | SKIN SCRUB TRAY | Dec 27, 1994 | Unknown |
| K945021 | FLUFF GAUZE SPONGE | Dec 23, 1994 | Substantially Equivalent |
| K945019 | FLUFF GAUXZE ROLL | Dec 23, 1994 | Substantially Equivalent |
| K945020 | FLUFF GAUZE SPONGE | Dec 23, 1994 | Substantially Equivalent |
| K944880 | BODILY FLUID DISPOSAL KIT | Dec 15, 1994 | Substantially Equivalent |
| K941469 | IV START KIT | May 12, 1994 | Substantially Equivalent |
| K941468 | DEBRIDEMENT TRAY, INCISION AND DRAINAGE TRAY | May 12, 1994 | Substantially Equivalent |
| K941471 | CENTRAL LINE DRESSING CHANGE TRAY | May 12, 1994 | Substantially Equivalent |