FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
STANFORD STERILE LAP SPONGES
K Number: K792471
·
Decision Dec 20, 1979
Classifications
1
FEI Numbers
211
Registration Numbers
211
Same Product Code
110
Applicant Total
11
Review Days
17
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
- STANFORD STERILE LAP SPONGES
- K Number
- K792471
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4450
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Lukens Corp.
- Date Received
- December 3, 1979
- Decision Date
- December 20, 1979
- 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
Other Clearances by Lukens Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K880230 | SIXALYZER | Mar 16, 1988 | Substantially Equivalent |
| K800102 | STANFORD STERILE LAP SPONGES | Jan 28, 1980 | Substantially Equivalent |
| K791495 | LUKENS BONE WAX (GAMMA RADIATION) | Sep 24, 1979 | Substantially Equivalent |
| K770797 | TRAY, CATHETERIZATION W/FOLEY, STERILE | Jul 11, 1977 | Substantially Equivalent |
| K770795 | SHAVE PREP SET | Jul 11, 1977 | Substantially Equivalent |
| K770799 | TRAY, IRRIGATION, STERILE, BASIC | Jun 22, 1977 | Substantially Equivalent |
| K770796 | SKIN SCRUB PREP SET | Jun 22, 1977 | Substantially Equivalent |
| K770794 | SUTURE REMOVAL SET, STERILE | May 6, 1977 | Substantially Equivalent |
| K770798 | BLADES, SURGICAL, STERILE | May 6, 1977 | Substantially Equivalent |
| K770800 | HANDLES, BLADE, SURGICAL | May 6, 1977 | Substantially Equivalent |