GCTClass II

Light Source, Endoscope, Xenon Arc

21 CFR 876.1500 / Gastroenterology, Urology

GCT is the FDA product code for Light Source, Endoscope, Xenon Arc, a class II device type, regulated under 21 CFR 876.1500. As of 2026-09-10, FDA records hold 47 510(k) clearances under this code, the most recent dated 2010-01-27, and 3 recalls.

Classification record

Product code: GCT
Device name: Light Source, Endoscope, Xenon Arc
Regulation: 21 CFR 876.1500
Device class: Class II
Review panel: Gastroenterology, Urology
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 47
Ingested recalls: 3

Clearances, product code GCT

By decision year

47 clearances under product code GCT with a decision year between 1979 and 2010, 1994 the highest year at 7.

Show the numbers

510(k) clearances under FDA product code GCT by decision year
Year	Clearances
1979	1
1986	1
1991	5
1992	2
1993	4
1994	7
1995	7
1996	3
1997	1
1998	4
1999	2
2001	1
2002	2
2003	3
2004	1
2007	1
2008	1
2010	1

Applicants with the most clearances

Product code GCT

Applicants holding the most 510(k) clearances under product code GCT
Applicant	Clearances
Karl Storz Endoscopy-America, Inc.	4
Richard Wolf Medical Instruments Corp.	4
World of Medicine Lemke GmbH	3
Cogent Light Technologies, Inc.	2
Contec Medical Vision, Ltd.	2
Laser-Optik-Systeme GmbH & Co. KG	2
Pentax Precision Instrument Corp.	2
Welch Allyn Inc	2
Acueity, Inc.	1
Angiolaz, Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 35 companies shown, in name order