FDA.reportPublic FDA data

ZKSK

Primary DI
06934415012089
Brand
ZKSK
Company
Beijing ZKSK Technology Co.,Ltd
Model
HC-16-165/26P
Device description
Disposable Hemoclip
Published
2024-03-06
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
PKLHemostatic Metal Clip For The Gi Tract

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PKLHemostatic Metal Clip For The Gi TractGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K213217000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213217000Disposable hemoclipBeijing Zksk Technology Co., Ltd.2022-11-14PKL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06934415012089PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06934415012089069344150120896934415012089

GMDN Terms#

Term, Definition table
TermDefinition
Gastrointestinal endoscopic clip, short-termA sterile clip intended to be placed short-term (<=30 days) within the gastrointestinal (GI) tract during an endoscopic procedure for endoscopic marking, haemostasis, tissue approximation, closure of luminal perforations, and/or for treating mucosal/submucosal defects. It is a metallic device with a clasping mechanism; a disposable applicator may be included. 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
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06934415027274ZKSKBF19-BC18-6002026-09-30
06934415027281ZKSKBF19-BC18-8002026-09-30
06934415027298ZKSKBF19-BC18-10502026-09-30
06934415027304ZKSKBF19-BC18-12002026-09-30
06934415027311ZKSKBF19-BC18-16002026-09-30
06934415027328ZKSKBF19-BC18-18002026-09-30
06934415027335ZKSKBF19-BC18-20002026-09-30
06934415027342ZKSKBF19-BC18-23002026-09-30
06934415027557ZKSKBF19-EC18-3002026-09-30
06934415027564ZKSKBF19-EC18-5002026-09-30
06934415027571ZKSKBF19-EC18-6002026-09-30
06934415027588ZKSKBF19-EC18-8002026-09-30
06934415027595ZKSKBF19-EC18-10502026-09-30
06934415027601ZKSKBF19-EC18-12002026-09-30
06934415027618ZKSKBF19-EC18-16002026-09-30
06934415027625ZKSKBF19-EC18-18002026-09-30
06934415027632ZKSKBF19-EC18-20002026-09-30
06934415027649ZKSKBF19-EC18-23002026-09-30
06934415027656ZKSKBF19-FC18-3002026-09-30
06934415027663ZKSKBF19-FC18-5002026-09-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06936603238059HemoclipYangzhou Fartley Medical Instrument Technology Co., LtdPKL2026-10-22
06936603238066HemoclipYangzhou Fartley Medical Instrument Technology Co., LtdPKL2026-10-22
06936603238073HemoclipYangzhou Fartley Medical Instrument Technology Co., LtdPKL2026-10-22
16926839818887NAAnrei Medical(HZ) Co.,Ltd.PKL2026-10-19
16926839818917NAAnrei Medical(HZ) Co.,Ltd.PKL2026-10-19
03760441721113Taurus Clip MiniTAURUS ENDOSCOPYPKL2026-09-22
03760441721212Taurus Clip MiniTAURUS ENDOSCOPYPKL2026-09-22
03760441722110Taurus ClipTAURUS ENDOSCOPYPKL2026-09-22
03760441722219Taurus ClipTAURUS ENDOSCOPYPKL2026-09-22
03760441723117Taurus Clip HemoTAURUS ENDOSCOPYPKL2026-09-22
03760441723216Taurus Clip HemoTAURUS ENDOSCOPYPKL2026-09-22
06959664900086NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-19
06959664900178NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-19
06959664900185NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-19
06959664900192NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-19
06959664900291NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-19
06959664900307NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-19
06959664900314NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-19
06959664900543NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-19
06959664900550NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-19
06959664900574NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-19
06959664900598NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-19
06959664900635NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-19
06959664900666NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-19
06959664900697NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-19
06959664900840NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-19
06959664900864NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-19
06959664900871NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-19
06959664900888NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-19
06959664900895NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-19