Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

GCI — Predicate Candidate Screening

14 FDA 510(k) clearances under this product code; the 50 most recent screened below.

93 daysmedian FDA review time

271 days90th percentile

14clearances measured

K-number	Device	Applicant	Decided	Review days
K021747	DEGALL LAPAROSCOPIC GALLBLADDER EXTRACTOR	Surgicon, Inc.	2002-08-15	79
K003222	MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER	Computer Motion, Inc.	2000-11-03	18
K001362	KARL STORZ 3D VIDEO SYSTEM	Karl Storz Imaging, Inc.	2000-07-17	80
K933515	BOOTY ENDOSCOPE WARMER	T-Med, Inc.	1993-10-27	99
K930302	BIRTCHER SURE CLEAN INSTRUMENT SYSTEM	Birtcher Medical Systems, Inc.	1993-10-27	279
K930496	GI-1090,1095,1080,1085,1086,1088, ENDO. CLAMPS	Birtcher Medical Systems, Inc.	1993-04-20	78
K922123	AUTO SUTURE DISPOSABLE ENDOSCOPIC SPECIMEN POUCH	United States Surgical, A Division of Tyco Healthc	1993-02-01	271
K920139	GLEESON CLOT-BUSTER	Conmedcorp	1992-04-15	93
K915762	POOLE TIP SUCTION PROBE	O.R. Concepts, Inc.	1992-03-13	80
K914120	SINGLE USE LAPAROSCOPY ELECTROSURGICAL INSTRUMENT	Conmedcorp	1991-10-30	47
K911829	ENDOSTAPLE	ETHICON, Inc.	1991-08-28	126
K905117	ENDOSCOPE AND ACCESSORIES	Northgate Technologies, Inc.	1991-04-25	163
K911461	SURGITRON	Ellman Intl. Mfg., Inc.	1991-04-25	22
K896205	MONOSCOPY BRAND, 5 MM LOCKING TROCAR SLEEVE	Dexide, Inc.	1990-03-22	147

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda