FDA.reportPublic FDA data

ZKSK

Primary DI
06934415066655
Brand
ZKSK
Company
Beijing ZKSK Technology Co.,Ltd
Model
BL18-6A
Device description
Multi-Band Ligator
Published
2023-07-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

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
K213223000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213223000Multi-Band LigatorBeijing Zksk Technology Co., Ltd.2022-06-06FHN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06934415066655PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06934415066655069344150666556934415066655

GMDN Terms#

Term, Definition table
TermDefinition
Oesophageal endoscopic ligator, single-useA device used in combination with a compatible flexible endoscope for the deployment of a rubber band to oesophageal varices during an endoscopic procedure which will create a haemostasis or necrosis of the varix. It is available in various designs and typically consists of a multiple band ligating unit that fits over the distal end of the endoscope with rubber latex ligating bands premounted on a band carrier, and controls that run along the outside of the endoscope terminating in a control handle at the proximal end that is used to deploy the bands as required. In some instances, this type of device could be used to treat haemorrhoids in the colon. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+8615773188175shawna@bjzksk.com

Regulatory Flags#

DUNS number
542947117
Device count
1
Lot or batch
true
Expiration date on label
true
Contains natural rubber latex
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04046955063413AESCULAPAESCULAP, INC.FHN2026-06-06
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.MND2026-02-14
06932503532853Multiple Band Ligator SetMicro-Tech (Nanjing) Co., Ltd.FHN2026-02-14
06932503532860Multiple Band Ligator SetMicro-Tech (Nanjing) Co., Ltd.MND2026-02-14
06932503532860Multiple Band Ligator SetMicro-Tech (Nanjing) Co., Ltd.FHN2026-02-14
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.MND2026-02-14
06932503532891Multiple Band Ligator SetMicro-Tech (Nanjing) Co., Ltd.FHN2026-02-14
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.MND2026-02-14
06932503532938Multiple Band Ligator SetMicro-Tech (Nanjing) Co., Ltd.FHN2026-02-14
06932503532945Multiple Band Ligator SetMicro-Tech (Nanjing) Co., Ltd.MND2026-02-14
06932503532945Multiple Band Ligator SetMicro-Tech (Nanjing) Co., Ltd.FHN2026-02-14
08033638801710Self-Suction-LEMSAPI MED SPAFHN2026-02-06