Atlas FDA

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

Global Endoscopy, Inc. — Predicate Candidate Screening

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

119 daysmedian FDA review time
226 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K003802HYSTEROSCOPESGlobal Endoscopy, Inc.2001-07-222260
K003805GYNECOLOGICAL LAPAROSCOPESGlobal Endoscopy, Inc.2001-07-222260
K003831ARTHROSCOPESGlobal Endoscopy, Inc.2001-07-202210
K003830ENT ENDOSCOPESGlobal Endoscopy, Inc.2001-04-091190
K003803GENERAL SURGICAL LAPAROSCOPESGlobal Endoscopy, Inc.2001-03-07890
K003806URETEROSCOPESGlobal Endoscopy, Inc.2001-02-22760
K003807CYSTOSCOPESGlobal Endoscopy, Inc.2001-02-22760

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