EPT · Microscope, Surgical
General, Plastic Surgery · 21 CFR 878.4700 · Class 1
Overview
| Product Code | EPT |
|---|---|
| Device Name | Microscope, Surgical |
| 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.
Recent Cleared Devices (18 of 18)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K942233 | MKM (MULTIPLE COORDINATE MANIPULATOR) SYSTEM | Carl Zeiss, Inc. | Jul 1, 1994 | SESE |
| K931284 | MICRODYNE OFFICE SURGICAL MICROSCOPE | Microdyne, Inc. | Nov 18, 1993 | SESE |
| K933310 | MICRINS CONTRAST BACKGROUND MATERIAL | Micrins Surgical, Inc. | Aug 19, 1993 | SESE |
| K903412 | STORZ MODEL M705 AND/OR M706 CEILING MOUNTED MICR. | Storz Instrument Co. | Sep 20, 1990 | SESE |
| K883581 | OPMI CS | Carl Zeiss, Inc. | Sep 13, 1988 | SESE |
| K882269 | STORZ DIAGNOSTIC MICROSCOPE SYSTEM | Storz Instrument Co. | Jun 23, 1988 | SESE |
| K860811 | ZEISS VOICE CONTROL SYSTEM FOR OPMI'S | Carl Zeiss, Inc. | Apr 30, 1986 | SESE |
| K844858 | STORZ/URBAN SURGICAL MICROSCOPE SYSTEM | Storz Instrument Co. | Mar 25, 1985 | SESE |
| K832887 | ELECTRONIC UNIT | Surgi-Quip Inc.U | Oct 4, 1983 | SESE |
| K823011 | VC III | Teknar, Inc. | Nov 8, 1982 | SESE |
| K822561 | MICROSCOPE | Treace Medical, Inc. | Sep 14, 1982 | SESE |
| K822014 | NAGASHIMA SU-A CEILING MOUNT UNIT FOR | Kelleher Corp. | Aug 6, 1982 | SESE |
| K822009 | BINOCULAR OPERATING MICROSCOPES & | Kelleher Corp. | Jul 30, 1982 | SESE |
| K821689 | LEBANON MICROSCOPE | The Lebanon Corp. | Jul 9, 1982 | SESE |
| K812234 | STORZ/OLYMPUS MICROSCOPE SYSTEM | Storz Instrument Co. | Sep 11, 1981 | SESE |
| K802904 | MICROSCOPE MODEL OM-U | Jedmed Instrument Co. | Feb 4, 1981 | SESE |
| K802903 | MICROSCOPE MODEL OM-P | Jedmed Instrument Co. | Feb 4, 1981 | SESE |
| K760696 | 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
