Product code EPT— General, Plastic Surgery
BINOCULAR OPERATING MICROSCOPES &
- Classification name
- Microscope, Surgical
- Device class
- Class 1
- Regulation
- 21 CFR 878.4700
- Advisory panel
- General, Plastic Surgery
- Total cleared
- 18
- First cleared
- Most recent
Market context for product code EPT
FDA has cleared devices under product code EPT between 1976 and 1994, filed by 11 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Clearances per year
- 1994
- 1993
- 1990
- 1988
- 1986
- 1985
- 1983
- 1982
- 1981
- 1976
Top applicants under product code EPT
Recent clearances under product code EPT
- K942233 — MKM (MULTIPLE COORDINATE MANIPULATOR) SYSTEM
- K931284 — MICRODYNE OFFICE SURGICAL MICROSCOPE
- K933310 — MICRINS CONTRAST BACKGROUND MATERIAL
- K903412 — STORZ MODEL M705 AND/OR M706 CEILING MOUNTED MICR.
- K883581 — OPMI CS
- K882269 — STORZ DIAGNOSTIC MICROSCOPE SYSTEM
- K860811 — ZEISS VOICE CONTROL SYSTEM FOR OPMI'S
- K844858 — STORZ/URBAN SURGICAL MICROSCOPE SYSTEM
- K832887 — ELECTRONIC UNIT
- K823011 — VC III
- K822561 — MICROSCOPE
- K822014 — NAGASHIMA SU-A CEILING MOUNT UNIT FOR
- K822009 — BINOCULAR OPERATING MICROSCOPES &
- K821689 — LEBANON MICROSCOPE
- K812234 — STORZ/OLYMPUS MICROSCOPE SYSTEM
- K802903 — MICROSCOPE MODEL OM-P
- K802904 — MICROSCOPE MODEL OM-U
- K760696 — REMOTE CONTROL SYSTEM FOR MICROSCOPE
Data sourced from openFDA. This site is unofficial and independent of the FDA.