Data / Medical devices / United States / Ellusa, LLC
Ellusa, LLC: FDA-registered device maker in Baldwin, NY, United States, 4 510(k) clearances
Ellusa, LLC is registered with the FDA (registration 3016087306) in Baldwin, NY, United States. It lists 1 device type. The FDA files 4 510(k) clearances under its listings, the newest dated September 9, 2022. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3016087306
- Address
- 2473 Grand Avenue, Baldwin, NY, United States, 11510
- Owner or operator
- Ellusa, LLC (10061959)
- Roles
- Manufacturer, Specification developer
- First device listed
- November 10, 2020
- Registered through
- 2026
- Brand names listed
- Ellusa Bipolar Wands, Ellusa Generator and Monopolar Tips and Accessories, Reusable Bipolar Cable, Reusable Neutral Plate
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 9, 2022 | K222429 | Ellusa Reusable Bipolar Cable | GEI | Substantially Equivalent | Ellusa, LLC | accessdata.fda.gov |
| September 8, 2022 | K222425 | Ellusa Reusable Neutral Plates | GEI | Substantially Equivalent | Ellusa, LLC | accessdata.fda.gov |
| November 2, 2020 | K202562 | Ellusa Generator, Ellusa Bayonet Tip, Ellusa RF-Cobb Tip, Ellusa SP-Pack and Tips, Ellusa Tip Set | GEI | Substantially Equivalent | Ellusa, LLC | accessdata.fda.gov |
| November 2, 2020 | K202558 | Ellusa Bipolar Wands | GEI | Substantially Equivalent | Ellusa, LLC | accessdata.fda.gov |
Compare with other makers
Updated September 9, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.