FDA.reportPublic FDA data

ZKSK

Primary DI
06934415012003
Brand
ZKSK
Company
Beijing ZKSK Technology Co.,Ltd
Model
HC-8-165/26P
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
06934415012003PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06934415012003069344150120036934415012003

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
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
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
06959664900901NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-19
06959664900918NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-19
06959664901144NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-19
06959664901151NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-19
06959664902813NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-19
06959664902820NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-19
06959664902837NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-19
06959664902851NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-19
06959664969526NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-19
06959664969533NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-19
06959664969540NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-19