Atlas FDA

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

Ethicon Endo-Sugery, LLC — Predicate Candidate Screening

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

127 daysmedian FDA review time
333 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K112033ENSEAL G2 TISSUS SEALERSEthicon Endo-Sugery, LLC2011-11-081165
K101990ETHICON ENDO-SURGERY GENERATOR G11, MODEL GEN11Ethicon Endo-Sugery, LLC2011-06-133330
K110699LIGAMAX 5Ethicon Endo-Sugery, LLC2011-03-25110
K091211EES SINGLE SITE LAPAROSCOPIC SEAL CAP ASSEMBLY W/ACCESSORIESEthicon Endo-Sugery, LLC2009-09-041300
K082278MAMMOMARK, MAMMOMARK MR AND CORMARK BIOPSY SITE IDENTIFIERSEthicon Endo-Sugery, LLC2008-12-161270
K080972ECHELON ZEBRA CARTRIDGES, MODELS, Z45WB, Z45BG, Z45GP, Z60WBEthicon Endo-Sugery, LLC2008-07-03900

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