FDA 510(k)
FDA class 1
Substantially Equivalent
🇨🇦 Canada
CASF STERILIZATION TRAY
K Number: K883125
·
Decision Aug 10, 1988
Classifications
1
FEI Numbers
875
Registration Numbers
875
Same Product Code
75
Applicant Total
9
Review Days
15
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
- CASF STERILIZATION TRAY
- K Number
- K883125
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Terray Manufacturing, Inc.
- Date Received
- July 26, 1988
- Decision Date
- August 10, 1988
- 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 Terray Manufacturing, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K910874 | THORACIC ANTERIOR SPINAL FIXATION PLATE | Feb 3, 1992 | Substantially Equivalent |
| K882934 | CASF CANCELLOUS BONE SCREW, BT650 | Oct 13, 1988 | Substantially Equivalent |
| K882871 | CASF DRILL GUIDE DG 170 | Sep 23, 1988 | Substantially Equivalent for Some Indications |
| K883193 | CASF STERILIZATION TRAY | Aug 10, 1988 | Substantially Equivalent |
| K870085 | ANTERIOR SPINAL FIXATION PLATE | Jun 30, 1987 | Substantially Equivalent |
| K870082 | BONE PLATE | May 6, 1987 | Substantially Equivalent |
| K870083 | FERRAY EXTRACTOR | Feb 26, 1987 | Substantially Equivalent |
| K870084 | RD 140 SURGICAL BENDER | Jan 28, 1987 | Substantially Equivalent |