EPT — Microscope, Surgical Class I
FDA product code EPT covers "Microscope, Surgical", a Class I medical device regulated under 21 CFR 878.4700. Submissions are reviewed by the General, Plastic Surgery panel. At least 18 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- EPT
- Device Class
- Class I
- Regulation Number
- 878.4700
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K942233 | carl zeiss | MKM (MULTIPLE COORDINATE MANIPULATOR) SYSTEM | July 1, 1994 |
| K931284 | microdyne | MICRODYNE OFFICE SURGICAL MICROSCOPE | November 18, 1993 |
| K933310 | micrins surgical | MICRINS CONTRAST BACKGROUND MATERIAL | August 19, 1993 |
| K903412 | storz instrument | STORZ MODEL M705 AND/OR M706 CEILING MOUNTED MICR. | September 20, 1990 |
| K883581 | carl zeiss | OPMI CS | September 13, 1988 |
| K882269 | storz instrument | STORZ DIAGNOSTIC MICROSCOPE SYSTEM | June 23, 1988 |
| K860811 | carl zeiss | ZEISS VOICE CONTROL SYSTEM FOR OPMI'S | April 30, 1986 |
| K844858 | storz instrument | STORZ/URBAN SURGICAL MICROSCOPE SYSTEM | March 25, 1985 |
| K832887 | surgi-quip inc.u | ELECTRONIC UNIT | October 4, 1983 |
| K823011 | teknar | VC III | November 8, 1982 |
| K822561 | treace medical | MICROSCOPE | September 14, 1982 |
| K822014 | kelleher | NAGASHIMA SU-A CEILING MOUNT UNIT FOR | August 6, 1982 |
| K822009 | kelleher | BINOCULAR OPERATING MICROSCOPES & | July 30, 1982 |
| K821689 | lebanon | LEBANON MICROSCOPE | July 9, 1982 |
| K812234 | storz instrument | STORZ/OLYMPUS MICROSCOPE SYSTEM | September 11, 1981 |
| K802904 | jedmed instrument | MICROSCOPE MODEL OM-U | February 4, 1981 |
| K802903 | jedmed instrument | MICROSCOPE MODEL OM-P | February 4, 1981 |
| K760696 | alcon laboratories | REMOTE CONTROL SYSTEM FOR MICROSCOPE | December 16, 1976 |