Microscope, Surgical
The surgical microscope is an optical instrument providing magnified, high-resolution visualization of the operative field, used across many surgical disciplines including ENT, neurosurgery, and general surgery. It is classified as FDA Class 1, indicating minimal risk, and is subject only to general controls without a premarket notification requirement. The product code is EPT, regulated under 21 CFR 878.4700 in the General, Plastic Surgery specialty. No special regulatory flags apply.
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Basic Information
- Product Code
- EPT
- 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 18 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K942233 | MKM (MULTIPLE COORDINATE MANIPULATOR) SYSTEM | Jul 01, 1994 | Substantially Equivalent | Carl Zeiss, Inc. |
| K931284 | MICRODYNE OFFICE SURGICAL MICROSCOPE | Nov 18, 1993 | Substantially Equivalent | Microdyne, Inc. |
| K933310 | MICRINS CONTRAST BACKGROUND MATERIAL | Aug 19, 1993 | Substantially Equivalent | Micrins Surgical, Inc. |
| K903412 | STORZ MODEL M705 AND/OR M706 CEILING MOUNTED MICR. | Sep 20, 1990 | Substantially Equivalent | Storz Instrument Co. |
| K883581 | OPMI CS | Sep 13, 1988 | Substantially Equivalent | Carl Zeiss, Inc. |
| K882269 | STORZ DIAGNOSTIC MICROSCOPE SYSTEM | Jun 23, 1988 | Substantially Equivalent | Storz Instrument Co. |
| K860811 | ZEISS VOICE CONTROL SYSTEM FOR OPMI'S | Apr 30, 1986 | Substantially Equivalent | Carl Zeiss, Inc. |
| K844858 | STORZ/URBAN SURGICAL MICROSCOPE SYSTEM | Mar 25, 1985 | Substantially Equivalent | Storz Instrument Co. |
| K832887 | ELECTRONIC UNIT | Oct 04, 1983 | Substantially Equivalent | Surgi-Quip Inc.U |
| K823011 | VC III | Nov 08, 1982 | Substantially Equivalent | Teknar, Inc. |
| K822561 | MICROSCOPE | Sep 14, 1982 | Substantially Equivalent | Treace Medical, Inc. |
| K822014 | NAGASHIMA SU-A CEILING MOUNT UNIT FOR | Aug 06, 1982 | Substantially Equivalent | Kelleher Corp. |
| K822009 | BINOCULAR OPERATING MICROSCOPES & | Jul 30, 1982 | Substantially Equivalent | Kelleher Corp. |
| K821689 | LEBANON MICROSCOPE | Jul 09, 1982 | Substantially Equivalent | The Lebanon Corp. |
| K812234 | STORZ/OLYMPUS MICROSCOPE SYSTEM | Sep 11, 1981 | Substantially Equivalent | Storz Instrument Co. |
| K802904 | MICROSCOPE MODEL OM-U | Feb 04, 1981 | Substantially Equivalent | Jedmed Instrument Co. |
| K802903 | MICROSCOPE MODEL OM-P | Feb 04, 1981 | Substantially Equivalent | Jedmed Instrument Co. |
| K760696 | REMOTE CONTROL SYSTEM FOR MICROSCOPE | Dec 16, 1976 | Substantially Equivalent | Alcon Laboratories |
FEI Numbers
This FDA classification entry is associated with 77 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 77 registration numbers. Click on an entry to view related FDA registrations.