GCIClass II

Laryngoscope, Endoscope

21 CFR 876.1500 / Gastroenterology, Urology

GCI is the FDA product code for Laryngoscope, Endoscope, a class II device type, regulated under 21 CFR 876.1500. As of 2026-09-10, FDA records hold 14 510(k) clearances under this code, the most recent dated 2002-08-15, and 5 recalls.

Classification record

Product code: GCI
Device name: Laryngoscope, Endoscope
Regulation: 21 CFR 876.1500
Device class: Class II
Review panel: Gastroenterology, Urology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 14
Ingested recalls: 5

Clearances, product code GCI

By decision year

14 clearances under product code GCI with a decision year between 1990 and 2002, 1991 the highest year at 4.

Show the numbers

510(k) clearances under FDA product code GCI by decision year
Year	Clearances
1990	1
1991	4
1992	2
1993	4
2000	2
2002	1

Applicants with the most clearances

Product code GCI

Applicants holding the most 510(k) clearances under product code GCI
Applicant	Clearances
Birtcher Medical Systems, Inc.	2
Conmedcorp	2
Computer Motion, Inc.	1
Dexide, Inc.	1
Ethicon, Inc	1
Ellman Intl. Mfg., Inc.	1
Karl Storz Imaging, Inc.	1
Northgate Technologies Inc.	1
O.R. Concepts, Inc.	1
Surgicon AG	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 32 companies shown, in name order