EPT · Class I · 21 CFR 878.4700

FDA Product Code EPT: Microscope, Surgical

Leading manufacturers include Storz Instrument Co., Carl Zeiss, Inc. and Jedmed Instrument Co..

18
Total
18
Cleared
60d
Avg days
1976
Since

FDA 510(k) Cleared Microscope, Surgical Devices (Product Code EPT)

18 devices
1–18 of 18
Cleared Jul 01, 1994
MKM (MULTIPLE COORDINATE MANIPULATOR) SYSTEM
K942233
Carl Zeiss, Inc.
General & Plastic Surgery · 53d
Cleared Sep 20, 1990
STORZ MODEL M705 AND/OR M706 CEILING MOUNTED MICR.
K903412
Storz Instrument Co.
General & Plastic Surgery · 52d
Cleared Sep 13, 1988
OPMI CS
K883581
Carl Zeiss, Inc.
General & Plastic Surgery · 22d
Cleared Jun 23, 1988
STORZ DIAGNOSTIC MICROSCOPE SYSTEM
K882269
Storz Instrument Co.
General & Plastic Surgery · 23d
Cleared Apr 30, 1986
ZEISS VOICE CONTROL SYSTEM FOR OPMI'S
K860811
Carl Zeiss, Inc.
General & Plastic Surgery · 57d
Cleared Mar 25, 1985
STORZ/URBAN SURGICAL MICROSCOPE SYSTEM
K844858
Storz Instrument Co.
General & Plastic Surgery · 101d
Cleared Sep 14, 1982
MICROSCOPE
K822561
Treace Medical, Inc.
General & Plastic Surgery · 21d
Cleared Aug 06, 1982
NAGASHIMA SU-A CEILING MOUNT UNIT FOR
K822014
Kelleher Corp.
General & Plastic Surgery · 29d
Cleared Jul 30, 1982
BINOCULAR OPERATING MICROSCOPES &
K822009
Kelleher Corp.
General & Plastic Surgery · 22d
Cleared Sep 11, 1981
STORZ/OLYMPUS MICROSCOPE SYSTEM
K812234
Storz Instrument Co.
Hematology · 31d
Cleared Feb 04, 1981
MICROSCOPE MODEL OM-P
K802903
Jedmed Instrument Co.
General & Plastic Surgery · 79d
Cleared Feb 04, 1981
MICROSCOPE MODEL OM-U
K802904
Jedmed Instrument Co.
General & Plastic Surgery · 79d
Cleared Dec 16, 1976
REMOTE CONTROL SYSTEM FOR MICROSCOPE
K760696
Alcon Laboratories
General & Plastic Surgery · 85d

About Product Code EPT - Regulatory Context