Microscope, Surgical, General & Plastic Surgery
A surgical microscope for general and plastic surgery is an optical instrument providing high magnification and illumination, used to enable precise visualization during delicate operative procedures. It is classified as FDA Class 1 (lowest risk), subject to general controls only, and does not require premarket notification. The product code is FSO, regulated under 21 CFR 878.4700, within the General, Plastic Surgery medical specialty. No special flags apply to this device.
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Basic Information
- Product Code
- FSO
- Device Class
- FDA class 1
- Regulation Number
- 878.4700
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 15 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K942304 | MICROFLEX | Jun 13, 1994 | Substantially Equivalent | Moeller Microsurgical, Inc. |
| K941399 | OPERATING MICROSCOPE AA OM 10 | Apr 22, 1994 | Substantially Equivalent | Appasamy Associates (U.S.A.), Inc. |
| K920689 | DEEMED MSS -- MICROSCOPE SUPPORT SYSTEM | Nov 12, 1993 | Substantially Equivalent | Deemed, Inc. |
| K926288 | SOM 6VI (SURGICAL OPERATING MICROSCOPE) | Oct 12, 1993 | Substantially Equivalent | Jedmed Instrument Co. |
| K931303 | WOODLYN OPERATION MICROSCOPE | Jun 25, 1993 | Substantially Equivalent | Woodlyn, Inc. |
| K926513 | MOLLER-WEDEL OPERATING MICROSCOPE | Jun 22, 1993 | Substantially Equivalent | Moeller Microsurgical, Inc. |
| K910357 | SOM 6V | Feb 19, 1991 | Substantially Equivalent | Jedmed Instrument Co. |
| K902076 | J2 MICROSCOPE | Aug 01, 1990 | Substantially Equivalent | Jedmed Instrument Co. |
| K874241 | OPMI MD SURGICAL MICROSCOPE | Dec 23, 1987 | Substantially Equivalent | Carl Zeiss, Inc. |
| K822562 | ODONTO-SCOPE | Oct 06, 1982 | Substantially Equivalent | Treace Medical, Inc. |
| K822181 | BINOCULAR OPER. MICROSCOPES & ACCESSOR | Aug 27, 1982 | Substantially Equivalent | Kelleher Corp. |
| K822015 | BINOCULAR OPERATING MICROSCOPES AND | Jul 30, 1982 | Substantially Equivalent | Kelleher Corp. |
| K802713 | FMS-02 FLOOR-UNIT MODEL MICROSCOPE | Nov 19, 1980 | Substantially Equivalent | Jedmed Instrument Co. |
| K801314 | VOCON MODEL VC526 | Sep 09, 1980 | Substantially Equivalent | Teknar, Inc. |
| K791280 | OPERATION MICROSCOPE SOM 1 | Jul 24, 1979 | Substantially Equivalent | Elmed, Inc. |
FEI Numbers
This FDA classification entry is associated with 44 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 44 registration numbers. Click on an entry to view related FDA registrations.