FDA.reportPublic FDA data

Liger Medical

Primary DI
00861592000300
Brand
Liger Medical
Company
LIGER MEDICAL, LLC
Model
ESU-110
Device description
Battery-powered electrosurgical generator.
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, Cutting & Coagulation & Accessories
HGIElectrocautery, Gynecologic (And Accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2
HGIElectrocautery, Gynecologic (And Accessories)Obstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K133273000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K133273000LIGER MEDICAL ESU-110Liger Medical, LLC2014-02-12GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00861592000300PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00861592000300008615920003008615920003000861592000300

GMDN Terms#

Term, Definition table
TermDefinition
Electrocautery system generator, battery-poweredA battery-powered device that produces and delivers a regulated electrical current used to heat the electrode tip or wire loop of a cutting instrument used during surgical intervention to burn or sear body tissue. It is used to stop bleeding (cauterization of blood vessels), to treat superficial skin lesions, e.g., the removal of warts, the removal of gastrointestinal polyps via an appropriate endoscope, or to occlude fallopian tubes during sterilization procedures. It will typically contain electronic circuits and have a built-in thermocoupler to help control the temperature at the electrode. This is not an electrosurgical diathermy system.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
035280324
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290016976106Liger MedicalEVA Pro Digital Colposcope2026-06-02
00860005151004Liger MedicalIRIS Thermocoagulator and Digital Colposcope Unit2026-05-05
00861592000324Cure MedicalHTU-1102016-09-23
00861592000331Cure MedicalHTU-110 16mm Flat2016-09-23
00861592000348Cure MedicalHTU-110 19mm Flat2016-09-23
00861592000355Cure MedicalHTU-110 19mm Nipple Probe2016-09-23

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08809306764140VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
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08809306764164VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764171VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764188VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
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