FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ULTRACELL ORTHOPEDIC SPONGES
K Number: K950373
·
Decision Apr 17, 1995
Classifications
1
FEI Numbers
211
Registration Numbers
211
Same Product Code
110
Applicant Total
24
Review Days
76
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Basic Information
- Device Name
- ULTRACELL ORTHOPEDIC SPONGES
- K Number
- K950373
- 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
- Ultracell Medical Technologies, Inc.
- Date Received
- January 31, 1995
- Decision Date
- April 17, 1995
- 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
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
Other Clearances by Ultracell Medical Technologies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K012196 | ULTRACELL ABSORBENT STICK | Aug 24, 2001 | Substantially Equivalent |
| K972633 | ULTRACELL SUCTION SPONGE | Dec 17, 1997 | Substantially Equivalent |
| K972634 | ULTRACELL SUCTION SPONGE | Dec 17, 1997 | Substantially Equivalent |
| K973083 | ULTRACELL NEURO SPONGES | Dec 9, 1997 | Substantially Equivalent |
| K973558 | VISUAL ENDOSCOPIC NON-ALCOHOL ULTRACELL SPONGE (VENUS) | Nov 24, 1997 | Substantially Equivalent |
| K973085 | ULTRACELL PACKING WITH SLEEVE | Nov 18, 1997 | Substantially Equivalent |
| K972635 | ULTRACELL SUCTION SPONGE | Oct 1, 1997 | Substantially Equivalent |
| K970328 | ULTRACELL NEURO SPONGES | Apr 21, 1997 | Substantially Equivalent |
| K950647 | ULTRACELL NEURO SPONGES | Aug 15, 1995 | Substantially Equivalent |
| K950370 | ULTRACELL ORTHOPEDIC SPONGES | Apr 17, 1995 | Substantially Equivalent |