FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
RCT-1, RCT-2, RCT-3 ARTHROGRAM TRAY
K Number: K870417
·
Decision Mar 5, 1987
Classifications
1
FEI Numbers
875
Registration Numbers
875
Same Product Code
75
Applicant Total
6
Review Days
30
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Basic Information
- Device Name
- RCT-1, RCT-2, RCT-3 ARTHROGRAM TRAY
- K Number
- K870417
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- North Coast Medi-Tek
- Date Received
- February 3, 1987
- Decision Date
- March 5, 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
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SURGICAL INSTRUMENT TRAY
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ARTHROSCOPY TRAY
FDA 510(k)
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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 North Coast Medi-Tek
| K Number | Device Name | ||
|---|---|---|---|
| K870419 | IVR-SP CUSTOM ANGIOGRAPHY TRAY | May 11, 1987 | Substantially Equivalent |
| K870420 | PTC-6 AND PTC-8 PERCUTANEOUS CHOLANGIOGRAPHY | Apr 14, 1987 | Unknown |
| K870416 | LP EXTENSION SETS | Apr 6, 1987 | Substantially Equivalent |
| K870418 | MYA-1 AND MYT-1 MYELOGRAM TRAY | Mar 17, 1987 | Substantially Equivalent |
| K854095 | BIOPSY TRAY I & II | Nov 25, 1985 | Unknown |