GCT · Class II · 21 CFR 876.1500

FDA Product Code GCT: Light Source, Endoscope, Xenon Arc

Leading manufacturers include Richard Wolf Medical Instruments Corp., KARL STORZ Endoscopy-America, Inc. and Welch Allyn, Inc..

47
Total
47
Cleared
94d
Avg days
1979
Since
47 devices
25–47 of 47
Cleared Oct 05, 1992
SYSTEM 3000 XENON VIDEOLAP LIGHT
K923210
Cabot Medical Corp.
Gastroenterology & Urology · 96d
Cleared Oct 08, 1991
MARLOW VERRES NEEDLES
K913586
Marlo Surgical Technology
Gastroenterology & Urology · 57d
Cleared Aug 14, 1991
ENDOSCOPIC LIGHT SOURCE
K911492
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 132d
Cleared Dec 24, 1986
THE KEYMED HI-LIGHT 250 LIGHT SOURCE
K864801
Keymed, Inc.
Gastroenterology & Urology · 15d
Cleared Dec 10, 1979
PENTEX UPPER G.I. SCOPE MODEL FG-28A
K792215
Pentax Precision Instrument Corp.
Gastroenterology & Urology · 35d