Data / Medical devices / United States / Elliquence LLC

Elliquence LLC: FDA-registered device maker in Baldwin, NY, United States, 13 510(k) clearances

Name: Elliquence LLC FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Elliquence LLC is registered with the FDA (registration 3007024186) in Baldwin, NY, United States. It lists 20 device types. The FDA files 13 510(k) clearances under its listings, the newest dated January 24, 2025. Registered through 2027. FDA data exported November 3, 2026.

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FDA registration number: 3007024186
Address: 2455 Grand Avenue, Baldwin, NY, United States, 11510
Owner or operator: Elliquence LLC (10024988)
Roles: Complaint file establishment, Manufacturer, Specification developer
First device listed: March 6, 2008
Registered through: 2027
Brand names listed: Ace Tip Electrodes, AxCess

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Cleaning Brushes, For Endoscope	MNL	1	Specification developer	accessdata.fda.gov
Arthroscope	HRX	2	Manufacturer	accessdata.fda.gov
Cannula, Surgical, General & Plastic Surgery	GEA	1	Manufacturer	accessdata.fda.gov
Chisel, Surgical, Manual	FZO	1	Manufacturer, Specification developer	accessdata.fda.gov
Dissector, Surgical, General & Plastic Surgery	GDI	1	Manufacturer	accessdata.fda.gov
Electrosurgical, Cutting & Coagulation & Accessories	GEI	2	Manufacturer	accessdata.fda.gov
Elevator, Surgical, General & Plastic Surgery	GEG	1	Manufacturer	accessdata.fda.gov
Forceps, General & Plastic Surgery	GEN	1	Specification developer	accessdata.fda.gov
Guide, Needle, Surgical	GDF	1	Manufacturer, Specification developer	accessdata.fda.gov
Instrument, Cutting, Orthopedic	HTZ	1	Specification developer	accessdata.fda.gov
Instrument, Manual, Surgical, General Use	MDM	1	Specification developer	accessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, Lumbar	MAX	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Mallet	HXL	1	Specification developer	accessdata.fda.gov
Motor, Surgical Instrument, Ac-Powered	GEY	1	Specification developer	accessdata.fda.gov
Probe	HXB	1	Manufacturer	accessdata.fda.gov
Punch, Surgical	LRY	1	Specification developer	accessdata.fda.gov
Retractor	GAD	1	Manufacturer	accessdata.fda.gov
Rongeur	HTX	1	Specification developer	accessdata.fda.gov
Scissors, Orthopedic, Surgical	HRR	1	Specification developer	accessdata.fda.gov
Tray, Surgical, Instrument	FSM	1	Manufacturer	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
January 24, 2025	K243739	AxCess® Expandable Interbody System	MAX	Substantially Equivalent	Elliquence, LLC	accessdata.fda.gov
June 11, 2018	K180766	Endiscope, Endiscope Cervical	HRX	Substantially Equivalent	Elliquence, LLC	accessdata.fda.gov
May 3, 2017	K170107	Surgi Max Ultra	GEI	Substantially Equivalent	Elliquence, LLC	accessdata.fda.gov
January 6, 2017	K162490	Disc-FX System	GEI	Substantially Equivalent	Elliquence, LLC	accessdata.fda.gov
March 7, 2016	K160041	Cobbra RF Tissue Dissector	GEI	Substantially Equivalent	Elliquence, LLC	accessdata.fda.gov
October 30, 2015	K142410	Elliquence Electrodes	GEI	Substantially Equivalent	Elliquence, LLC	accessdata.fda.gov
October 8, 2013	K130110	MEDDUSA BIPOLAR SYSTEM	GEI	Substantially Equivalent	Elliquence, LLC	accessdata.fda.gov
August 25, 2010	K100390	SURGIMAX/ SURGIMAX PLUS	GEI	Substantially Equivalent	Elliquence, LLC	accessdata.fda.gov
February 28, 2008	K071343	ELLMAN NOBLE ALLOY ELECTRODES	GEI	Substantially Equivalent	Ellman International, Inc.	accessdata.fda.gov
June 28, 2006	K061174	SURGI-MAX	GEI	Substantially Equivalent	Ellman Int'L, Inc.	accessdata.fda.gov
February 24, 2006	K052241	DISC-FX SYSTEM	HRX	Substantially Equivalent	Ellman International, Inc.	accessdata.fda.gov
April 11, 2001	K003126	BIPOLAR TRIGGER-FLEX PROBE	GEI	Substantially Equivalent	Ellman Intl., Inc.	accessdata.fda.gov
August 14, 1997	K964176	TECNO REUSABLE, ELECTROSURGICAL, BIPOLAR FORCEPS	GEI	Substantially Equivalent	Tecno Instruments (Usa), Inc.	accessdata.fda.gov

Compare with other makers

Updated January 24, 2025. 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.