FCW · Class II · 21 CFR 876.1500

FDA Product Code FCW: Light Source, Fiberoptic, Routine

Leading manufacturers include KARL STORZ Endoscopy-America, Inc., Pilling Co. and Welch Allyn, Inc..

31
Total
31
Cleared
80d
Avg days
1976
Since
31 devices
25–31 of 31
Cleared Jan 13, 1987
LUXTEC LIGHT SOURCES
K864385
Luxtec Corp.
Gastroenterology & Urology · 69d
Cleared Aug 27, 1985
WELCH ALLYN FIBER OPTIC CABLES VARIOUS MODELS
K852951
Welch Allyn, Inc.
Gastroenterology & Urology · 47d
Cleared Aug 09, 1984
R.L. MEDICAL TWIN LIGHT SOURCE
K842609
Tridak Division of Indicon, Inc.
Gastroenterology & Urology · 35d
Cleared Oct 19, 1983
PEDIATRIC ILLUMINATING URETERAL
K832807
Van-Tec, Inc.
Gastroenterology & Urology · 62d
Cleared Sep 30, 1977
PENTAX LH-150F LIGHT SOURCE
K771739
Pilling Co.
Gastroenterology & Urology · 15d
Cleared Dec 06, 1976
ADAPTER, FIBER OPTICS HEADLIGHT
K760647
Pilling Co.
Gastroenterology & Urology · 82d
Cleared Aug 30, 1976
FLOORSTAND, FIBER OPTIC LIGHT SOURCE
K760176
V. Mueller O.V. Baxter Healthcare Corp.
Gastroenterology & Urology · 55d