FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
STERILE SUTURE REMOVAL SET
K Number: K832047
·
Decision Sep 12, 1983
Classifications
1
FEI Numbers
329
Registration Numbers
330
Same Product Code
61
Applicant Total
23
Review Days
80
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
- STERILE SUTURE REMOVAL SET
- K Number
- K832047
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Ormed Mfg., Inc.
- Date Received
- June 24, 1983
- Decision Date
- September 12, 1983
- Product Code
- KDD
- 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 |
|---|---|---|---|
| KDD | Kit, Surgical Instrument, Disposable | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KDD), ordered by most recent decision date.
CONVENIENCE KIT FOR SINGLE-INCISION LAPAROSCOPIC SURGERY AND OTHER ADVANCED LAPAROSCOPIC PROCEDURES
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
INSTRUMENTS FOR ONE TIME USE - DISPOSABLE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
NATIONAL MEDICAL HEALTHCARE CUSTOM ORTHOPEDIC KITS AND TRAYS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
DENVER PARACENTESIS NEEDLE(60-1200) DENVER PARACENTESIS NEEDLE WITH DRAINAGE LINE(60-1100) DENVER PARACENTESIS TRAY
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
CUSTOM CV PACK
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
SUTURE SET OR LACERATION TRAYS (PACKS)
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 |