Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart E — Surgical Devices](/submissions/SU/subpart-e%E2%80%94surgical-devices) → [21 CFR 878.4700](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4700) → FSO — Microscope, Surgical, General & Plastic Surgery

# FSO · Microscope, Surgical, General & Plastic Surgery

_General, Plastic Surgery · 21 CFR 878.4700 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FSO

## Overview

- **Product Code:** FSO
- **Device Name:** Microscope, Surgical, General & Plastic Surgery
- **Regulation:** [21 CFR 878.4700](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4700)
- **Device Class:** 1
- **Review Panel:** [General, Plastic Surgery](/submissions/SU)

## 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.

## Recent Cleared Devices (15 of 15)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K942304](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FSO/K942304.md) | MICROFLEX | Moeller Microsurgical, Inc. | Jun 13, 1994 | SESE |
| [K941399](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FSO/K941399.md) | OPERATING MICROSCOPE AA OM 10 | Appasamy Associates (U.S.A.), Inc. | Apr 22, 1994 | SESE |
| [K920689](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FSO/K920689.md) | DEEMED MSS -- MICROSCOPE SUPPORT SYSTEM | Deemed, Inc. | Nov 12, 1993 | SESE |
| [K926288](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FSO/K926288.md) | SOM 6VI (SURGICAL OPERATING MICROSCOPE) | Jedmed Instrument Co. | Oct 12, 1993 | SESE |
| [K931303](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FSO/K931303.md) | WOODLYN OPERATION MICROSCOPE | Woodlyn, Inc. | Jun 25, 1993 | SESE |
| [K926513](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FSO/K926513.md) | MOLLER-WEDEL OPERATING MICROSCOPE | Moeller Microsurgical, Inc. | Jun 22, 1993 | SESE |
| [K910357](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FSO/K910357.md) | SOM 6V | Jedmed Instrument Co. | Feb 19, 1991 | SESE |
| [K902076](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FSO/K902076.md) | J2 MICROSCOPE | Jedmed Instrument Co. | Aug 1, 1990 | SESE |
| [K874241](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FSO/K874241.md) | OPMI MD SURGICAL MICROSCOPE | Carl Zeiss, Inc. | Dec 23, 1987 | SESE |
| [K822562](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FSO/K822562.md) | ODONTO-SCOPE | Treace Medical, Inc. | Oct 6, 1982 | SESE |
| [K822181](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FSO/K822181.md) | BINOCULAR OPER. MICROSCOPES & ACCESSOR | Kelleher Corp. | Aug 27, 1982 | SESE |
| [K822015](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FSO/K822015.md) | BINOCULAR OPERATING MICROSCOPES AND | Kelleher Corp. | Jul 30, 1982 | SESE |
| [K802713](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FSO/K802713.md) | FMS-02 FLOOR-UNIT MODEL MICROSCOPE | Jedmed Instrument Co. | Nov 19, 1980 | SESE |
| [K801314](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FSO/K801314.md) | VOCON MODEL VC526 | Teknar, Inc. | Sep 9, 1980 | SESE |
| [K791280](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FSO/K791280.md) | OPERATION MICROSCOPE SOM 1 | Elmed, Inc. | Jul 24, 1979 | SESE |

## Top Applicants

- Jedmed Instrument Co. — 4 clearances
- Kelleher Corp. — 2 clearances
- Moeller Microsurgical, Inc. — 2 clearances
- Appasamy Associates (U.S.A.), Inc. — 1 clearance
- Carl Zeiss, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FSO](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FSO)

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