FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
STERILIZATION TRAY, TMJ INSTRUMENT SET
K Number: K871924
·
Decision Jun 1, 1987
Classifications
1
FEI Numbers
875
Registration Numbers
875
Same Product Code
75
Applicant Total
29
Review Days
14
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
- STERILIZATION TRAY, TMJ INSTRUMENT SET
- K Number
- K871924
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Arthropedics, Inc.
- Date Received
- May 18, 1987
- Decision Date
- June 1, 1987
- Product Code
- FSM
- 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 |
|---|---|---|---|
| FSM | Tray, Surgical, Instrument | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FSM), ordered by most recent decision date.
INSTRUMENT TRAY LINER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
SINGLE USE INSTRUMENT TRAY
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
SURGICAL INSTRUMENT TRAY
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ARTHROSCOPY TRAY
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
OPEN HEART TRAY
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
HEART CATH TRAY
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by Arthropedics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K873619 | ARTHROSCOPIC RETENTION-MANIPULATION SYSTEM (ARMS) | Jan 14, 1988 | Substantially Equivalent |
| K873655 | MONOPOLAR CAUTERY RETROGADE TIP #TM-1703 | Dec 15, 1987 | Substantially Equivalent |
| K873653 | MONOPOLAR CAUTERY BLADE TIP #TM-1701 | Dec 15, 1987 | Substantially Equivalent |
| K873654 | MONOPOLAR CAUTERY CONICAL TIP #TM-1702 | Dec 15, 1987 | Substantially Equivalent |
| K873387 | VIDEO ARTHROSCOPE, 1.7MM X 55 MM | Nov 25, 1987 | Substantially Equivalent |
| K873504 | CUP BIOPSY FORCEPS, RIGHT | Nov 2, 1987 | Substantially Equivalent |
| K872533 | THE CART | Nov 2, 1987 | Substantially Equivalent |
| K873501 | SCISSOR, LEFT | Nov 2, 1987 | Substantially Equivalent |
| K873502 | SCISSOR, RIGHT | Nov 2, 1987 | Substantially Equivalent |
| K873512 | SERRATED GRASPING FORCEPS, RIGHT | Nov 2, 1987 | Substantially Equivalent |