Atlas FDA

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

Conmed Endoscopic Technologies, Inc. · Predicate Candidate Screening

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

K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K091355DEUCE POLYPECTOMY SNARE, MODELS 000995, 000996,000997, 00099Conmed Endoscopic Technologies, Inc.2009-07-22750
K080946CONMED AXCESS PAPILLOTOME MODELS AX4535, AX4535FXConmed Endoscopic Technologies, Inc.2008-05-20470

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