FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
GAUZE, NONABSORABABLE, X-RAY DETECTABLE (INTERNAL SPONGE)
K Number: K951911
·
Decision Jun 21, 1995
Classifications
1
FEI Numbers
211
Registration Numbers
211
Same Product Code
110
Applicant Total
1
Review Days
58
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- GAUZE, NONABSORABABLE, X-RAY DETECTABLE (INTERNAL SPONGE)
- K Number
- K951911
- 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
- Commercial Resources New Mexico, Ltd.
- Date Received
- April 24, 1995
- Decision Date
- June 21, 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
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
CPR LAP SPONGES
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
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