FSO
15 FDA 510(k) clearances · Product code
43 daysmedian time to decision
302 days90th percentile
15clearances measured
FDA profile
- Official device name
- Microscope, Surgical, General & Plastic Surgery
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4700
- Medical specialty
- General, Plastic Surgery
- Adverse events (MAUDE)
- 2017: 14 · 2018: 11 · 2019: 12 · 2021: 19 · 2023: 17 · 2025: 17
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| MICROFLEX (K942304) | Moeller Microsurgical, Inc. | 1994-06-13 |
| OPERATING MICROSCOPE AA OM 10 (K941399) | Appasamy Associates (U.S.A.), Inc. | 1994-04-22 |
| DEEMED MSS -- MICROSCOPE SUPPORT SYSTEM (K920689) | Deemed, Inc. | 1993-11-12 |
| SOM 6VI (SURGICAL OPERATING MICROSCOPE) (K926288) | Jedmed Instrument Co. | 1993-10-12 |
| WOODLYN OPERATION MICROSCOPE (K931303) | Woodlyn, Inc. | 1993-06-25 |
| MOLLER-WEDEL OPERATING MICROSCOPE (K926513) | Moeller Microsurgical, Inc. | 1993-06-22 |
| SOM 6V (K910357) | Jedmed Instrument Co. | 1991-02-19 |
| J2 MICROSCOPE (K902076) | Jedmed Instrument Co. | 1990-08-01 |
| OPMI MD SURGICAL MICROSCOPE (K874241) | Carl Zeiss, Inc. | 1987-12-23 |
| ODONTO-SCOPE (K822562) | Treace Medical, Inc. | 1982-10-06 |
| BINOCULAR OPER. MICROSCOPES & ACCESSOR (K822181) | Kelleher Corp. | 1982-08-27 |
| BINOCULAR OPERATING MICROSCOPES AND (K822015) | Kelleher Corp. | 1982-07-30 |
| FMS-02 FLOOR-UNIT MODEL MICROSCOPE (K802713) | Jedmed Instrument Co. | 1980-11-19 |
| VOCON MODEL VC526 (K801314) | Teknar, Inc. | 1980-09-09 |
| OPERATION MICROSCOPE SOM 1 (K791280) | Elmed, Inc. | 1979-07-24 |
Track FSO automatically
Every clearance here is in the API, with alerts when new ones post.