Product code FSO
- Device name
- Microscope, Surgical, General & Plastic Surgery
- Medical specialty
- General, Plastic Surgery
- Device class
- 1
- Regulation number
- 878.4700
- Review panel
- SU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K942304 | MICROFLEX | Moeller Microsurgical, Inc. | 1994-06-13 |
| K941399 | OPERATING MICROSCOPE AA OM 10 | Appasamy Associates (U.S.A.), Inc. | 1994-04-22 |
| K920689 | DEEMED MSS -- MICROSCOPE SUPPORT SYSTEM | Deemed, Inc. | 1993-11-12 |
| K926288 | SOM 6VI (SURGICAL OPERATING MICROSCOPE) | Jedmed Instrument Co. | 1993-10-12 |
| K931303 | WOODLYN OPERATION MICROSCOPE | Woodlyn, Inc. | 1993-06-25 |
| K926513 | MOLLER-WEDEL OPERATING MICROSCOPE | Moeller Microsurgical, Inc. | 1993-06-22 |
| K910357 | SOM 6V | Jedmed Instrument Co. | 1991-02-19 |
| K902076 | J2 MICROSCOPE | Jedmed Instrument Co. | 1990-08-01 |
| K874241 | OPMI MD SURGICAL MICROSCOPE | Carl Zeiss, Inc. | 1987-12-23 |
| K822562 | ODONTO-SCOPE | Treace Medical, Inc. | 1982-10-06 |
| K822181 | BINOCULAR OPER. MICROSCOPES & ACCESSOR | Kelleher Corp. | 1982-08-27 |
| K822015 | BINOCULAR OPERATING MICROSCOPES AND | Kelleher Corp. | 1982-07-30 |
| K802713 | FMS-02 FLOOR-UNIT MODEL MICROSCOPE | Jedmed Instrument Co. | 1980-11-19 |
| K801314 | VOCON MODEL VC526 | Teknar, Inc. | 1980-09-09 |
| K791280 | OPERATION MICROSCOPE SOM 1 | Elmed, Inc. | 1979-07-24 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 06945095527848 | zumax | Zumax Medical Co., LTD | 2026-07-06 |
| 06945095527817 | zumax | Zumax Medical Co., LTD | 2026-07-06 |
| 06945095527794 | zumax | Zumax Medical Co., LTD | 2026-07-06 |
| 06945095527787 | zumax | Zumax Medical Co., LTD | 2026-07-06 |
| 06945095527763 | zumax | Zumax Medical Co., LTD | 2026-07-06 |
| 06945095527756 | zumax | Zumax Medical Co., LTD | 2026-07-06 |
| 06945095527749 | zumax | Zumax Medical Co., LTD | 2026-07-06 |
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