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) → EPT — Microscope, Surgical

# EPT · Microscope, Surgical

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

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

## Overview

- **Product Code:** EPT
- **Device Name:** Microscope, Surgical
- **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 (18 of 18)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K942233](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/EPT/K942233.md) | MKM (MULTIPLE COORDINATE MANIPULATOR) SYSTEM | Carl Zeiss, Inc. | Jul 1, 1994 | SESE |
| [K931284](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/EPT/K931284.md) | MICRODYNE OFFICE SURGICAL MICROSCOPE | Microdyne, Inc. | Nov 18, 1993 | SESE |
| [K933310](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/EPT/K933310.md) | MICRINS CONTRAST BACKGROUND MATERIAL | Micrins Surgical, Inc. | Aug 19, 1993 | SESE |
| [K903412](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/EPT/K903412.md) | STORZ MODEL M705 AND/OR M706 CEILING MOUNTED MICR. | Storz Instrument Co. | Sep 20, 1990 | SESE |
| [K883581](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/EPT/K883581.md) | OPMI CS | Carl Zeiss, Inc. | Sep 13, 1988 | SESE |
| [K882269](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/EPT/K882269.md) | STORZ DIAGNOSTIC MICROSCOPE SYSTEM | Storz Instrument Co. | Jun 23, 1988 | SESE |
| [K860811](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/EPT/K860811.md) | ZEISS VOICE CONTROL SYSTEM FOR OPMI'S | Carl Zeiss, Inc. | Apr 30, 1986 | SESE |
| [K844858](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/EPT/K844858.md) | STORZ/URBAN SURGICAL MICROSCOPE SYSTEM | Storz Instrument Co. | Mar 25, 1985 | SESE |
| [K832887](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/EPT/K832887.md) | ELECTRONIC UNIT | Surgi-Quip Inc.U | Oct 4, 1983 | SESE |
| [K823011](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/EPT/K823011.md) | VC III | Teknar, Inc. | Nov 8, 1982 | SESE |
| [K822561](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/EPT/K822561.md) | MICROSCOPE | Treace Medical, Inc. | Sep 14, 1982 | SESE |
| [K822014](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/EPT/K822014.md) | NAGASHIMA SU-A CEILING MOUNT UNIT FOR | Kelleher Corp. | Aug 6, 1982 | SESE |
| [K822009](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/EPT/K822009.md) | BINOCULAR OPERATING MICROSCOPES & | Kelleher Corp. | Jul 30, 1982 | SESE |
| [K821689](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/EPT/K821689.md) | LEBANON MICROSCOPE | The Lebanon Corp. | Jul 9, 1982 | SESE |
| [K812234](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/EPT/K812234.md) | STORZ/OLYMPUS MICROSCOPE SYSTEM | Storz Instrument Co. | Sep 11, 1981 | SESE |
| [K802904](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/EPT/K802904.md) | MICROSCOPE MODEL OM-U | Jedmed Instrument Co. | Feb 4, 1981 | SESE |
| [K802903](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/EPT/K802903.md) | MICROSCOPE MODEL OM-P | Jedmed Instrument Co. | Feb 4, 1981 | SESE |
| [K760696](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/EPT/K760696.md) | REMOTE CONTROL SYSTEM FOR MICROSCOPE | Alcon Laboratories | Dec 16, 1976 | SESE |

## Top Applicants

- Storz Instrument Co. — 4 clearances
- Carl Zeiss, Inc. — 3 clearances
- Kelleher Corp. — 2 clearances
- Jedmed Instrument Co. — 2 clearances
- Treace Medical, Inc. — 1 clearance

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

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