FDA.reportPublic FDA data

ZKSK

Primary DI
06934415023207
Brand
ZKSK
Company
Beijing ZKSK Technology Co.,Ltd
Model
HE30-165-1
Device description
Disposable Ligation Device
Published
2024-01-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MNDLigator, Esophageal

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06934415023207PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06934415023207069344150232076934415023207

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

Contacts#

Phone, Email table
PhoneEmail
+86 13260186661barbie@bjzksk.com

Regulatory Flags#

DUNS number
542947117
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06934415028424ZKSKZKHG-24-30/2302026-05-18
06934415029865ZKSKZKHG-18-10/702026-05-18
06934415029872ZKSKZKHG-18-10/802026-05-18
06934415029889ZKSKZKHG-18-10/1202026-05-18
06934415029896ZKSKZKHG-18-10/1602026-05-18
06934415029902ZKSKZKHG-18-10/1802026-05-18
06934415029919ZKSKZKHG-18-10/2302026-05-18
06934415029926ZKSKZKHG-18-20/702026-05-18
06934415029933ZKSKZKHG-18-20/802026-05-18
06934415029940ZKSKZKHG-18-20/1202026-05-18
06934415029957ZKSKZKHG-18-20/1602026-05-18
06934415029964ZKSKZKHG-18-20/1802026-05-18
06934415029971ZKSKZKHG-18-20/2302026-05-18
06934415029988ZKSKZKHG-18-25/702026-05-18
06934415029995ZKSKZKHG-18-25/802026-05-18
06934415030007ZKSKZKHG-18-25/1202026-05-18
06934415030014ZKSKZKHG-18-25/1602026-05-18
06934415030021ZKSKZKHG-18-25/1802026-05-18
06934415030038ZKSKZKHG-18-25/2302026-05-18
06934415030045ZKSKZKHG-18-30/702026-05-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06932503532853Multiple Band Ligator SetMicro-Tech (Nanjing) Co., Ltd.MND2026-02-14
06932503532860Multiple Band Ligator SetMicro-Tech (Nanjing) Co., Ltd.MND2026-02-14
06932503532877Multiple Band Ligator SetMicro-Tech (Nanjing) Co., Ltd.MND2026-02-14
06932503532884Multiple Band Ligator SetMicro-Tech (Nanjing) Co., Ltd.MND2026-02-14
06932503532891Multiple Band Ligator SetMicro-Tech (Nanjing) Co., Ltd.MND2026-02-14
06932503532907Multiple Band Ligator SetMicro-Tech (Nanjing) Co., Ltd.MND2026-02-14
06932503532914Multiple Band Ligator SetMicro-Tech (Nanjing) Co., Ltd.MND2026-02-14
06932503532938Multiple Band Ligator SetMicro-Tech (Nanjing) Co., Ltd.MND2026-02-14
06932503532945Multiple Band Ligator SetMicro-Tech (Nanjing) Co., Ltd.MND2026-02-14
06932503532921Multiple Band Ligator SetMicro-Tech (Nanjing) Co., Ltd.MND2026-01-30
06923646508645Ligation DeviceLeo Medical Co., Ltd.MND2026-01-04
06923646508652Ligation DeviceLeo Medical Co., Ltd.MND2026-01-04
06923646508669Ligation DeviceLeo Medical Co., Ltd.MND2026-01-04
06923646508676Ligation DeviceLeo Medical Co., Ltd.MND2026-01-04
06923646508683Ligation DeviceLeo Medical Co., Ltd.MND2026-01-04
06923646508690Ligation DeviceLeo Medical Co., Ltd.MND2026-01-04
06923646508706Ligation DeviceLeo Medical Co., Ltd.MND2026-01-04
06923646508713Ligation DeviceLeo Medical Co., Ltd.MND2026-01-04
06923646508720Ligation DeviceLeo Medical Co., Ltd.MND2026-01-04
06923646508744Ligation DeviceLeo Medical Co., Ltd.MND2026-01-04
06923646508638Ligation DeviceLeo Medical Co., Ltd.MND2025-12-18
06923646508737Ligation DeviceLeo Medical Co., Ltd.MND2025-12-18
00724995247331SmartBand SafeGrip Multi-Band Ligation KitUS EndoscopyMND2025-11-21
00724995247348SmartBand SafeGrip Multi-Band Ligation PackUS EndoscopyMND2025-11-21
00724995247355SmartBand Ligation KitUS EndoscopyMND2025-11-21
00724995247362SmartBand Ligation PackUS EndoscopyMND2025-11-21
16934415066621ZKSKBeijing ZKSK Technology Co.,LtdMND2024-12-06
16934415066638ZKSKBeijing ZKSK Technology Co.,LtdMND2024-12-06
16934415066645ZKSKBeijing ZKSK Technology Co.,LtdMND2024-12-06
16934415066652ZKSKBeijing ZKSK Technology Co.,LtdMND2024-12-06