GCI

14 FDA 510(k) clearances · Product code

93 daysmedian time to decision

271 days90th percentile

14clearances measured

FDA profile

Official device name: Laryngoscope, Endoscope
Device class: Class II (moderate risk)
Regulation: 21 CFR 876.1500
Medical specialty: Gastroenterology, Urology
Flags: Third-party review eligible
Adverse events (MAUDE): 2021: 96 · 2022: 102 · 2023: 101 · 2024: 119 · 2025: 122 · 2026: 59
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

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Record	Firm	Date
DEGALL LAPAROSCOPIC GALLBLADDER EXTRACTOR (K021747)	Surgicon, Inc.	2002-08-15
MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER (K003222)	Computer Motion, Inc.	2000-11-03
KARL STORZ 3D VIDEO SYSTEM (K001362)	Karl Storz Imaging, Inc.	2000-07-17
BOOTY ENDOSCOPE WARMER (K933515)	T-Med, Inc.	1993-10-27
BIRTCHER SURE CLEAN INSTRUMENT SYSTEM (K930302)	Birtcher Medical Systems, Inc.	1993-10-27
GI-1090,1095,1080,1085,1086,1088, ENDO. CLAMPS (K930496)	Birtcher Medical Systems, Inc.	1993-04-20
AUTO SUTURE DISPOSABLE ENDOSCOPIC SPECIMEN POUCH (K922123)	United States Surgical, A Division of Tyco Healthc	1993-02-01
GLEESON CLOT-BUSTER (K920139)	Conmedcorp	1992-04-15
POOLE TIP SUCTION PROBE (K915762)	O.R. Concepts, Inc.	1992-03-13
SINGLE USE LAPAROSCOPY ELECTROSURGICAL INSTRUMENT (K914120)	Conmedcorp	1991-10-30
ENDOSTAPLE (K911829)	ETHICON, Inc.	1991-08-28
ENDOSCOPE AND ACCESSORIES (K905117)	Northgate Technologies, Inc.	1991-04-25
SURGITRON (K911461)	Ellman Intl. Mfg., Inc.	1991-04-25
MONOSCOPY BRAND, 5 MM LOCKING TROCAR SLEEVE (K896205)	Dexide, Inc.	1990-03-22

Track GCI automatically

Every clearance here is in the API, with alerts when new ones post.