FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
STERILE X-RAY DETECTABLE GAUZE SPONGES
K Number: K941522
·
Decision May 12, 1994
Classifications
1
FEI Numbers
211
Registration Numbers
211
Same Product Code
110
Applicant Total
23
Review Days
43
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Basic Information
- Device Name
- STERILE X-RAY DETECTABLE GAUZE SPONGES
- K Number
- K941522
- 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
- Cush Medical Products
- Date Received
- March 30, 1994
- Decision Date
- May 12, 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 Cush Medical Products
| K Number | Device Name | ||
|---|---|---|---|
| K943424 | CUSH ISLAND DRESSING | Oct 3, 1994 | Substantially Equivalent for Some Indications |
| K940518 | C-SECTION TRAY | Aug 18, 1994 | Unknown |
| K941349 | DENTAL TRAY | Jul 26, 1994 | Substantially Equivalent for Some Indications |
| K941645 | BIOPSY TRAY | Jul 14, 1994 | Unknown |
| K940239 | EYE TRAY | Jun 28, 1994 | Unknown |
| K935684 | IV START KIT | Jun 10, 1994 | Unknown |
| K941455 | STERILE GAUZE PRODUCT LINE | May 20, 1994 | Unknown |
| K941344 | LAP SPONGE PRODUCT LINE | May 12, 1994 | Substantially Equivalent |
| K935697 | CIRCUMCISION TRAY | May 2, 1994 | Unknown |
| K936120 | LABOR AND DELIVERY TRAY | Mar 30, 1994 | Unknown |