Atlas FDA

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

Elliquence, LLC — Predicate Candidate Screening

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

121 daysmedian FDA review time
428 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K243739AxCess® Expandable Interbody SystemElliquence, LLC2025-01-24510
K180766Endiscope, Endiscope CervicalElliquence, LLC2018-06-11800
K170107Surgi Max UltraElliquence, LLC2017-05-031110
K162490Disc-FX SystemElliquence, LLC2017-01-061210
K160041Cobbra RF Tissue DissectorElliquence, LLC2016-03-07590
K142410Elliquence ElectrodesElliquence, LLC2015-10-304280
K130110MEDDUSA BIPOLAR SYSTEMElliquence, LLC2013-10-082650
K100390SURGIMAX/ SURGIMAX PLUSElliquence, LLC2010-08-251900

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