Product code GCI— Gastroenterology, Urology

FDA has cleared 14 devices under product code GCI between 1990 and 2002, filed by 12 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 20021 clearance
• 20002 clearances
• 19934 clearances
• 19922 clearances
• 19914 clearances
• 19901 clearance

• Conmedcorp2 clearances
• Birtcher Medical Systems, Inc.2 clearances
• United States Surgical, A Division of Tyco Healthc1 clearance
• T-Med, Inc.1 clearance
• Surgicon, Inc.1 clearance
• O.R. Concepts, Inc.1 clearance
• Northgate Technologies, Inc.1 clearance
• Karl Storz Imaging, Inc.1 clearance
• ETHICON, Inc.1 clearance
• Ellman Intl. Mfg., Inc.1 clearance

Malfunction

635

Total

635

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• K021747 — DEGALL LAPAROSCOPIC GALLBLADDER EXTRACTORSurgicon, Inc.·2002-08-15
• K003222 — MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTERComputer Motion, Inc.·2000-11-03
• K001362 — KARL STORZ 3D VIDEO SYSTEMKarl Storz Imaging, Inc.·2000-07-17
• K930302 — BIRTCHER SURE CLEAN INSTRUMENT SYSTEMBirtcher Medical Systems, Inc.·1993-10-27
• K933515 — BOOTY ENDOSCOPE WARMERT-Med, Inc.·1993-10-27
• K930496 — GI-1090,1095,1080,1085,1086,1088, ENDO. CLAMPSBirtcher Medical Systems, Inc.·1993-04-20
• K922123 — AUTO SUTURE DISPOSABLE ENDOSCOPIC SPECIMEN POUCHUnited States Surgical, A Division of Tyco Healthc·1993-02-01
• K920139 — GLEESON CLOT-BUSTERConmedcorp·1992-04-15
• K915762 — POOLE TIP SUCTION PROBEO.R. Concepts, Inc.·1992-03-13
• K914120 — SINGLE USE LAPAROSCOPY ELECTROSURGICAL INSTRUMENTConmedcorp·1991-10-30
• K911829 — ENDOSTAPLEETHICON, Inc.·1991-08-28
• K905117 — ENDOSCOPE AND ACCESSORIESNorthgate Technologies, Inc.·1991-04-25
• K911461 — SURGITRONEllman Intl. Mfg., Inc.·1991-04-25
• K896205 — MONOSCOPY BRAND, 5 MM LOCKING TROCAR SLEEVEDexide, Inc.·1990-03-22