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

Usgi Medical — Predicate Candidate Screening

11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

25 daysmedian FDA review time

87 days90th percentile

11clearances measured

K-number	Device	Applicant	Decided	Review days
K103688	G-PROX EZ ENDOSCOPIC GRASPER	Usgi Medical	2011-01-14	28
K102931	G-CINCH SUTURE GRASPER	Usgi Medical	2010-12-30	87
K102916	G-CATH TISSUE ANCHOR DELIVERY CATHETER	Usgi Medical	2010-10-20	19
K100251	G-CATH TISSUE ANCHOR DELIVERY CATHETER, MODELS 205302, 20533	Usgi Medical	2010-02-17	20
K093018	G-PROX ENDOSCOPIC GRASPER, MODEL 205333	Usgi Medical	2009-10-07	29
K072405	USGI TRANSPORT ENDOSCOPIC ACCESS DEVICE	Usgi Medical	2007-09-13	17
K061276	G-PROX ENDOSCOPIC GRASPER	Usgi Medical	2006-12-06	212
K061268	G-LIX TISSUE GRASPER	Usgi Medical	2006-07-31	87
K061216	USGI TRANSPORT ENDOSCOPIC GUIDE	Usgi Medical	2006-05-15	13
K051919	MODIFICATION TO: USGI SHAPELOCK ENDOSCOPIC GUIDE	Usgi Medical	2005-07-26	11
K050253	USGI SHAPELOCK ENDOSCOPIC GUIDE	Usgi Medical	2005-02-28	25

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