FDA.reportPublic FDA data

Liger Medical

Primary DI
00860005151004
Brand
Liger Medical
Company
LIGER MEDICAL, LLC
Model
IRIS Thermocoagulator and Digital Colposcope Unit
Device description
IRIS Thermocoagulator and Digital Colposcope
Published
2026-05-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
HGIElectrocautery, Gynecologic (And Accessories)
PTZColposcope (And Colpomicroscope), Exempt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HGIElectrocautery, Gynecologic (And Accessories)Obstetrics/Gynecology2
PTZColposcope (And Colpomicroscope), ExemptObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K202915000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202915000IRIS Thermocoagulator and Digital ColposcopeLiger Medical, LLC2021-04-23HGI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860005151004PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860005151004008600051510048600051510040860005151004

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.

Regulatory Flags#

DUNS number
035280324
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00861592000300Liger MedicalESU-1102016-09-23
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10887482178222BovieASPEN SURGICAL PRODUCTS, INC.HGI2024-08-27
10887482178246BovieASPEN SURGICAL PRODUCTS, INC.HGI2024-08-27
10887482178260BovieASPEN SURGICAL PRODUCTS, INC.HGI2024-08-27