FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MODIFIED ROUND (BEEHIVE) DISSECTOR 3/8
K Number: K873391
·
Decision Sep 11, 1987
Classifications
1
FEI Numbers
211
Registration Numbers
211
Same Product Code
110
Applicant Total
23
Review Days
18
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
- MODIFIED ROUND (BEEHIVE) DISSECTOR 3/8
- K Number
- K873391
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4450
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Ormed Mfg., Inc.
- Date Received
- August 24, 1987
- Decision Date
- September 11, 1987
- 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 Ormed Mfg., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K931555 | ARTROMOT K2 CPM | Jan 31, 1994 | Substantially Equivalent |
| K882528 | CYLINDRICAL SPONGE | Jul 18, 1988 | Substantially Equivalent |
| K882530 | TAPE STRUNG TONSIL SPONGE | Jul 18, 1988 | Substantially Equivalent |
| K882529 | BUTCHER STRUNG TONSIL SPONGE | Jul 18, 1988 | Substantially Equivalent |
| K882527 | GAUZE SPONGE | Jul 18, 1988 | Substantially Equivalent |
| K880853 | CHERRY SPONGE | Mar 17, 1988 | Substantially Equivalent |
| K880907 | TRIANGLE SPONGE | Mar 17, 1988 | Substantially Equivalent |
| K880910 | ROUND STICK SPONGES | Mar 17, 1988 | Substantially Equivalent |
| K880911 | BLUNT SPONGE | Mar 17, 1988 | Substantially Equivalent |
| K880851 | FLAT STICK SPONGE | Mar 17, 1988 | Substantially Equivalent |