FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
INSTRUMENT STERILIZATION TRAY
K Number: K863726
·
Decision Oct 14, 1986
Classifications
1
FEI Numbers
875
Registration Numbers
875
Same Product Code
75
Applicant Total
5
Review Days
21
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
- INSTRUMENT STERILIZATION TRAY
- K Number
- K863726
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Medical Technology Development Corp.
- Date Received
- September 23, 1986
- Decision Date
- October 14, 1986
- 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 Medical Technology Development Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K941488 | DEVMED DOUBLE-BALLOON UROLOGICAL CATHETER | Nov 30, 1994 | Substantially Equivalent |
| K862315 | FYODOROV COLLAGEN CORNEAL SHIELD | Jan 7, 1987 | Substantially Equivalent |
| K863727 | FIXATION INSTRUMENTS | Oct 31, 1986 | Substantially Equivalent |
| K863725 | CATARACT DIAMOND KNIFE | Oct 31, 1986 | Substantially Equivalent |