Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009903460

FEI Number

3009903460

Entity Name

LIGER MEDICAL

City/State/Country

Lehi, UT, US

Establishment Address

3300 North Running Creek Way, Building G, Basement Suite G20, Lehi, UT 84043, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Liger Medical (Owner Number: 10048911)

Owner / Operator Contact Address

3300 North Running Creek Way, Building G, Basement Suite G20, Lehi, UT 84043, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K152843

PMA Number

N/A

All Registered Proprietary Names

EVA Pro Digital Colposcope ESU-110 Electrosurgery Generator IRIS HTU-110 ThermoCoagulator MobileODT ThermoGlide Thermocoagulation Device

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PTZ	Colposcope (And Colpomicroscope), Exempt	Obstetrics/Gynecology	Class 2	884.1630	2022-07-25
HGI	Electrocautery, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.4120	2015-03-18
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2015-03-18
PTZ	Colposcope (And Colpomicroscope), Exempt	Obstetrics/Gynecology	Class 2	884.1630	2021-10-22
HGI	Electrocautery, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.4120	2021-10-22
HGI	Electrocautery, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.4120	2016-09-12

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Liger Medical

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K970809	Somnus Medical Technologies, Inc.	BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL	1997-06-18
K222793	C.R. Bard, Inc.	WavelinQ Generator	2022-10-17
K002257	Tecno Instruments (Pvt.) , Ltd.	TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100	2000-10-19
K193591	Bowa-Electronics GmbH & Co. KG	ARC 400	2020-04-02
K192128	Sutter Medizintechnik GmbH	Sutter Arrowtip Monopolar Electrodes	2019-10-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-2013	Gynex Corporation	2	Sterile, single-use, disposable electrosurgical electrode holder. It connects the electrode to the foot activated electric generator. Label reads in part "*GYNEX* Electrode Handpiece, Foot Activated* Manufactured for GYNEX*" Gynex catalog number: 950 (Gynex REF 950, Electrode Handpiece) It connects the electrode to the food activated electric generator. Electrodes are used in gynecological procedures, in a physician's office, for cutting to remove tissue and coagulation to control bleeding by the use of high frequency current.
Z-0031-06	Rita Medical Systems	2	Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826

Similar Registrations

Registration Number	Establishment Name	Location
3003971136	EDAN INSTRUMENTS, INC.	Shenzhen Guangdong, CN
3003969012	Alltion (Guangxi) Instrument Co., Ltd.	Wuzhou City Guangxi, CN
3006252153	ZUMAX MEDICAL CO, LTD.	SUZHOU,JIANGSU, CN
3005527904	ATMOS INC.	Exton, PA, US
3009201600	SHENZHEN GOLDCARE MEDITECH CO., LTD.	Shenzhen Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009903460. Last updated year: 2026. Please use registration number 3009903460 when referencing this establishment in official correspondence.