FSO — Microscope, Surgical, General & Plastic Surgery Class I
FDA product code FSO covers "Microscope, Surgical, General & Plastic Surgery", a Class I medical device regulated under 21 CFR 878.4700. Submissions are reviewed by the General, Plastic Surgery panel. At least 15 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- FSO
- Device Class
- Class I
- Regulation Number
- 878.4700
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K942304 | moeller microsurgical | MICROFLEX | June 13, 1994 |
| K941399 | appasamy associates (u.s.a.) | OPERATING MICROSCOPE AA OM 10 | April 22, 1994 |
| K920689 | deemed | DEEMED MSS -- MICROSCOPE SUPPORT SYSTEM | November 12, 1993 |
| K926288 | jedmed instrument | SOM 6VI (SURGICAL OPERATING MICROSCOPE) | October 12, 1993 |
| K931303 | woodlyn | WOODLYN OPERATION MICROSCOPE | June 25, 1993 |
| K926513 | moeller microsurgical | MOLLER-WEDEL OPERATING MICROSCOPE | June 22, 1993 |
| K910357 | jedmed instrument | SOM 6V | February 19, 1991 |
| K902076 | jedmed instrument | J2 MICROSCOPE | August 1, 1990 |
| K874241 | carl zeiss | OPMI MD SURGICAL MICROSCOPE | December 23, 1987 |
| K822562 | treace medical | ODONTO-SCOPE | October 6, 1982 |
| K822181 | kelleher | BINOCULAR OPER. MICROSCOPES & ACCESSOR | August 27, 1982 |
| K822015 | kelleher | BINOCULAR OPERATING MICROSCOPES AND | July 30, 1982 |
| K802713 | jedmed instrument | FMS-02 FLOOR-UNIT MODEL MICROSCOPE | November 19, 1980 |
| K801314 | teknar | VOCON MODEL VC526 | September 9, 1980 |
| K791280 | elmed | OPERATION MICROSCOPE SOM 1 | July 24, 1979 |