FDA.reportPublic FDA data

Ligation Device

Primary DI
06923646508737
Brand
Ligation Device
Company
Leo Medical Co., Ltd.
Model
Loop30B0-LD230D0
Catalog number
Loop30B0-LD230D0
Published
2025-12-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FHNLigator, Hemorrhoidal
MNDLigator, Esophageal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FHNLigator, HemorrhoidalGastroenterology, Urology2
MNDLigator, EsophagealGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172985000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172985000Ligation DeviceLeo Medical Co., Ltd.2018-06-14FHN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06923646508737PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06923646508737069236465087376923646508737

GMDN Terms#

Term, Definition table
TermDefinition
Polypectomy endoscopic ligator, single-useA device used in combination with a compatible flexible endoscope for the deployment of a ligature loop (a self-locking device made of, e.g., a polymer in the form of a thin band) that is typically applied to large colorectal or pedunculated polyps in the gastrointestinal (GI) tract to prevent or control bleeding following polypectomy. It typically consists of an insertion sheath, the ligature loop at the distal end, and a control handle at the proximal end used to deploy the loop. This device may be used to ligate the appendix during its removal. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
421371962
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06923646504029Single-use Balloon Dilatation CatheterKZ0630E0KZ0630E02026-01-04
06923646504036Single-use Balloon Dilatation CatheterKZ0830E0KZ0830E02026-01-04
06923646504043Single-use Balloon Dilatation CatheterKZ1030E0KZ1030E02026-01-04
06923646504050Single-use Balloon Dilatation CatheterKZ1230E0KZ1230E02026-01-04
06923646504067Single-use Balloon Dilatation CatheterKZ1530E0KZ1530E02026-01-04
06923646504074Single-use Balloon Dilatation CatheterKZ0680F0KZ0680F02026-01-04
06923646504081Single-use Balloon Dilatation CatheterKZ0880F0KZ0880F02026-01-04
06923646504098Single-use Balloon Dilatation CatheterKZ1080F0KZ1080F02026-01-04
06923646504104Single-use Balloon Dilatation CatheterKZ1280F0KZ1280F02026-01-04
06923646504111Single-use Balloon Dilatation CatheterKZ1580F0KZ1580F02026-01-04
06923646504128Single-use Balloon Dilatation CatheterKZ1880F0KZ1880F02026-01-04
06923646504258Single-use Balloon Dilatation CatheterKZ0655H0KZ0655H02026-01-04
06923646504265Single-use Balloon Dilatation CatheterKZ0855H0KZ0855H02026-01-04
06923646504272Single-use Balloon Dilatation CatheterKZ1055H0KZ1055H02026-01-04
06923646504289Single-use Balloon Dilatation CatheterKZ1255H0KZ1255H02026-01-04
06923646504296Single-use Balloon Dilatation CatheterKZ1555H0KZ1555H02026-01-04
06923646504302Single-use Balloon Dilatation CatheterKZ1855H0KZ1855H02026-01-04
06923646504388Single-use Balloon Dilatation CatheterKZ0655G0KZ0655G02026-01-04
06923646504395Single-use Balloon Dilatation CatheterKZ0855G0KZ0855G02026-01-04
06923646504401Single-use Balloon Dilatation CatheterKZ1055G0KZ1055G02026-01-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05055445961923SurtexSURTEX INSTRUMENTS LTD.FHN2026-05-12
05055445961947SurtexSURTEX INSTRUMENTS LTD.FHN2026-05-12
05055445961954SurtexSURTEX INSTRUMENTS LTD.FHN2026-05-12
05055445961961SurtexSURTEX INSTRUMENTS LTD.FHN2026-05-12
05055445961978SurtexSURTEX INSTRUMENTS LTD.FHN2026-05-12
05055445961985SurtexSURTEX INSTRUMENTS LTD.FHN2026-05-12
05055445961992SurtexSURTEX INSTRUMENTS LTD.FHN2026-05-12
05055445962005SurtexSURTEX INSTRUMENTS LTD.FHN2026-05-12
05060937770006Haemoband-PLUS Band LigatorHaemoband SurgicalFHN2026-04-28
00860014651106LHC Power Bander LHC Power Bander LLCFHN2026-03-03
06932503532853Multiple Band Ligator SetMicro-Tech (Nanjing) Co., Ltd.FHN2026-02-14
06932503532853Multiple Band Ligator SetMicro-Tech (Nanjing) Co., Ltd.MND2026-02-14
06932503532860Multiple Band Ligator SetMicro-Tech (Nanjing) Co., Ltd.FHN2026-02-14
06932503532860Multiple Band Ligator SetMicro-Tech (Nanjing) Co., Ltd.MND2026-02-14
06932503532877Multiple Band Ligator SetMicro-Tech (Nanjing) Co., Ltd.MND2026-02-14
06932503532877Multiple Band Ligator SetMicro-Tech (Nanjing) Co., Ltd.FHN2026-02-14
06932503532884Multiple Band Ligator SetMicro-Tech (Nanjing) Co., Ltd.MND2026-02-14
06932503532884Multiple Band Ligator SetMicro-Tech (Nanjing) Co., Ltd.FHN2026-02-14
06932503532891Multiple Band Ligator SetMicro-Tech (Nanjing) Co., Ltd.FHN2026-02-14
06932503532891Multiple Band Ligator SetMicro-Tech (Nanjing) Co., Ltd.MND2026-02-14
06932503532907Multiple Band Ligator SetMicro-Tech (Nanjing) Co., Ltd.MND2026-02-14
06932503532907Multiple Band Ligator SetMicro-Tech (Nanjing) Co., Ltd.FHN2026-02-14
06932503532914Multiple Band Ligator SetMicro-Tech (Nanjing) Co., Ltd.MND2026-02-14
06932503532914Multiple Band Ligator SetMicro-Tech (Nanjing) Co., Ltd.FHN2026-02-14
06932503532938Multiple Band Ligator SetMicro-Tech (Nanjing) Co., Ltd.FHN2026-02-14
06932503532938Multiple Band Ligator SetMicro-Tech (Nanjing) Co., Ltd.MND2026-02-14
06932503532945Multiple Band Ligator SetMicro-Tech (Nanjing) Co., Ltd.FHN2026-02-14
06932503532945Multiple Band Ligator SetMicro-Tech (Nanjing) Co., Ltd.MND2026-02-14
08033638801710Self-Suction-LEMSAPI MED SPAFHN2026-02-06
06932503532921Multiple Band Ligator SetMicro-Tech (Nanjing) Co., Ltd.FHN2026-01-30