510(k) Report

FDA applicant

Ellusa, LLC

Baldwin, NY4 decisions2020–20220 recalls

FDA records 4 decisions for Ellusa, LLC (Baldwin, NY) from 2020 to 2022: 4 510(k) clearances. All are in product code GEI (Electrosurgical, Cutting & Coagulation &…). Since 2016 its 510(k)s took a median of 44 days from receipt to decision, against 128 for FDA’s reviews in the same codes and years. Its devices cite 4 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 Ellusa, LLC’s devices, and how often a recall has named them.

FDA decisions per year

2in 2022

2020: 22022: 2
2020high 2 (2020) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — Ellusa, LLC by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Ellusa, 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 & Accessories4decisions

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 44 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 128 days; 4 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 4 predicates; 2 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K202562Ellusa Generator, Ellusa Bayonet Tip, Ellusa RF-Cobb Tip, Ellusa SP-Pack and Tips, Ellusa Tip SetEllusa, LLC · 20201cites it
  • K202558Ellusa Bipolar WandsEllusa, LLC · 20201cites it

What has FDA decided for it lately?

  • K222429Ellusa Reusable Bipolar CableEllusa, LLC · 2022
  • K222425Ellusa Reusable Neutral PlatesEllusa, LLC · 2022
  • K202562Ellusa Generator, Ellusa Bayonet Tip, Ellusa RF-Cobb Tip, Ellusa SP-Pack and Tips, Ellusa Tip SetEllusa, LLC · 2020
  • K202558Ellusa Bipolar WandsEllusa, LLC · 2020

All 4 as Ellusa, LLC →