510(k) Report

FDA applicant

Elliquence, LLC

Baldwin, NY8 decisions2010–20250 recalls

FDA records 8 decisions for Elliquence, LLC (Baldwin, NY) from 2010 to 2025: 8 510(k) clearances. Most are in product codes GEI (Electrosurgical, Cutting & Coagulation &…) and HRX (Arthroscope). Since 2016 its 510(k)s took a median of 80 days from receipt to decision, against 85 for FDA’s reviews in the same codes and years. Its devices cite 16 predicates, 2 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Elliquence, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2010: 12013: 12015: 12016: 12017: 22018: 12025: 1
2010high 2 (2017) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

FIG. 1 — Elliquence, LLC by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Elliquence, LLC’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • GEIElectrosurgical, Cutting & Coagulation & Accessories6decisions
  • HRXArthroscope1decision
  • MAXIntervertebral Fusion Device With Bone Graft, Lumbar1decision

How long do its 510(k) reviews take?

Since 2016, its 5 510(k)s took a median of 80 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 85 days; 3 of its 5 were faster than that.

Whose devices does it build on?

Its devices cite 16 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 9 times; 2 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K100390Surgimax/ Surgimax PlusElliquence, LLC · 20102cite it
  • K170107Surgi Max UltraElliquence, LLC · 20172cite it
  • K142410Elliquence ElectrodesElliquence, LLC · 20152cite it
  • K180766Endiscope, Endiscope CervicalElliquence, LLC · 20181cites it
  • K160041Cobbra RF Tissue DissectorElliquence, LLC · 20161cites it
  • K130110Meddusa Bipolar SystemElliquence, LLC · 20131cites it

What has FDA decided for it lately?

  • K243739AxCess® Expandable Interbody SystemElliquence, LLC · 2025
  • K180766Endiscope, Endiscope CervicalElliquence, LLC · 2018
  • K170107Surgi Max UltraElliquence, LLC · 2017
  • K162490Disc-FX SystemElliquence, LLC · 2017
  • K160041Cobbra RF Tissue DissectorElliquence, LLC · 2016
  • K142410Elliquence ElectrodesElliquence, LLC · 2015
  • K130110Meddusa Bipolar SystemElliquence, LLC · 2013
  • K100390Surgimax/ Surgimax PlusElliquence, LLC · 2010

All 8 as Elliquence, LLC →