Elliquence LLC
Baldwin, NY, US
ELLIQUENCE LLC appears in FDA device records in Baldwin, NY. FDA records list 8 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 8 510(k) clearances for Elliquence LLC between 2010 and 2025. The busiest year on record is 2017, with 2. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2010 | 1 |
| 2013 | 1 |
| 2015 | 1 |
| 2016 | 1 |
| 2017 | 2 |
| 2018 | 1 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K243739 | AxCess® Expandable Interbody System | MAX | Substantially Equivalent | |
| K180766 | Endiscope, Endiscope Cervical | HRX | Substantially Equivalent | |
| K170107 | Surgi Max Ultra | GEI | Substantially Equivalent | |
| K162490 | Disc-FX System | GEI | Substantially Equivalent | |
| K160041 | Cobbra RF Tissue Dissector | GEI | Substantially Equivalent | |
| K142410 | Elliquence Electrodes | GEI | Substantially Equivalent | |
| K130110 | MEDDUSA BIPOLAR SYSTEM | GEI | Substantially Equivalent | |
| K100390 | SURGIMAX/ SURGIMAX PLUS | GEI | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3007024186 | 3007024186 | ELLIQUENCE LLC | 2455 Grand Avenue, Baldwin, NY 11510 US | 2026 | and 10 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- MNLAccessories, Cleaning Brushes, For Endoscope
- HRXArthroscope
- GEACannula, Surgical, General & Plastic Surgery
- FZOChisel, Surgical, Manual
- GDIDissector, Surgical, General & Plastic Surgery
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- GEGElevator, Surgical, General & Plastic Surgery
- GENForceps, General & Plastic Surgery
- GDFGuide, Needle, Surgical
- HTZInstrument, Cutting, Orthopedic
- MDMInstrument, Manual, Surgical, General Use
- MAXIntervertebral Fusion Device With Bone Graft, Lumbar
- HXLMallet
- GEYMotor, Surgical Instrument, Ac-Powered
- HXBProbe
- LRYPunch, Surgical
- GADRetractor
- HTXRongeur
- HRRScissors, Orthopedic, Surgical
- FSMTray, Surgical, Instrument
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain