FSO · Microscope, Surgical, General & Plastic Surgery
General, Plastic Surgery · 21 CFR 878.4700 · Class 1
Overview
| Product Code | FSO |
|---|---|
| Device Name | Microscope, Surgical, General & Plastic Surgery |
| Regulation | 21 CFR 878.4700 |
| Device Class | Class 1 |
| Review Panel | General, Plastic Surgery |
Identification
A surgical microscope and accessories is an AC-powered device intended for use during surgery to provide a magnified view of the surgical field.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
Cleared Devices (15)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K942304 | MICROFLEX | Moeller Microsurgical, Inc. | Jun 13, 1994 | SESE |
| K941399 | OPERATING MICROSCOPE AA OM 10 | Appasamy Associates (U.S.A.), Inc. | Apr 22, 1994 | SESE |
| K920689 | DEEMED MSS -- MICROSCOPE SUPPORT SYSTEM | Deemed, Inc. | Nov 12, 1993 | SESE |
| K926288 | SOM 6VI (SURGICAL OPERATING MICROSCOPE) | Jedmed Instrument Co. | Oct 12, 1993 | SESE |
| K931303 | WOODLYN OPERATION MICROSCOPE | Woodlyn, Inc. | Jun 25, 1993 | SESE |
| K926513 | MOLLER-WEDEL OPERATING MICROSCOPE | Moeller Microsurgical, Inc. | Jun 22, 1993 | SESE |
| K910357 | SOM 6V | Jedmed Instrument Co. | Feb 19, 1991 | SESE |
| K902076 | J2 MICROSCOPE | Jedmed Instrument Co. | Aug 1, 1990 | SESE |
| K874241 | OPMI MD SURGICAL MICROSCOPE | Carl Zeiss, Inc. | Dec 23, 1987 | SESE |
| K822562 | ODONTO-SCOPE | Treace Medical, Inc. | Oct 6, 1982 | SESE |
| K822181 | BINOCULAR OPER. MICROSCOPES & ACCESSOR | Kelleher Corp. | Aug 27, 1982 | SESE |
| K822015 | BINOCULAR OPERATING MICROSCOPES AND | Kelleher Corp. | Jul 30, 1982 | SESE |
| K802713 | FMS-02 FLOOR-UNIT MODEL MICROSCOPE | Jedmed Instrument Co. | Nov 19, 1980 | SESE |
| K801314 | VOCON MODEL VC526 | Teknar, Inc. | Sep 9, 1980 | SESE |
| K791280 | OPERATION MICROSCOPE SOM 1 | Elmed, Inc. | Jul 24, 1979 | SESE |
Top Applicants
- Jedmed Instrument Co. — 4 clearances
- Moeller Microsurgical, Inc. — 2 clearances
- Kelleher Corp. — 2 clearances
- Woodlyn, Inc. — 1 clearance
- Treace Medical, Inc. — 1 clearance
