FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CPR LAP SPONGES
K Number: K960236
·
Decision Mar 28, 1996
Classifications
1
FEI Numbers
211
Registration Numbers
211
Same Product Code
110
Applicant Total
21
Review Days
72
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Basic Information
- Device Name
- CPR LAP SPONGES
- K Number
- K960236
- 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
- Custom Pack Reliability
- Date Received
- January 16, 1996
- Decision Date
- March 28, 1996
- 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
FDA 510(k)
FDA Class 1
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STRYKER FEMORAL CANAL SPONGE & ACETABULUM SPONGE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
PROTEC X-RAY DETECTABLE GAUZE SPONGE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
KENSORB
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
TRIANGULAR SPONGES
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ROSEBUD DISSECTOR
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by Custom Pack Reliability
| K Number | Device Name | ||
|---|---|---|---|
| K960205 | CPR TRACHEOTOMY CARE TRAY | Aug 27, 1996 | Substantially Equivalent |
| K960243 | CPR C-SECTION DELIVERY PACK | May 23, 1996 | Substantially Equivalent |
| K960239 | CPR D & C TRAY | May 23, 1996 | Substantially Equivalent |
| K960216 | CPR SUCTION CATHETER KIT | Apr 15, 1996 | Substantially Equivalent |
| K960211 | CPR TOTAL KNEE PACK | Apr 12, 1996 | Substantially Equivalent |
| K960210 | CPR ORTHO HAND PACK | Apr 12, 1996 | Substantially Equivalent |
| K960206 | CPR DRESSING CHANGE TRAY | Apr 12, 1996 | Substantially Equivalent |
| K960213 | CPR TOTAL HIP PACK | Apr 12, 1996 | Substantially Equivalent |
| K960209 | CPR HEART PACK | Apr 4, 1996 | Substantially Equivalent |
| K960214 | CPR FOLEY CAHTETER KIT | Apr 1, 1996 | Substantially Equivalent |