FDA.reportPublic FDA data

ZKSK

Primary DI
06934415066150
Brand
ZKSK
Company
Beijing ZKSK Technology Co.,Ltd
Model
ES18-E1815/2400
Device description
Disposable Polypectomy Snare
Published
2023-12-25
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
FDISnare, Flexible

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FDISnare, FlexibleGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K213222000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213222000Disposable Polypectomy SnareBeijing Zksk Technology Co., Ltd.2022-06-06FDI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06934415066150PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06934415066150069344150661506934415066150

GMDN Terms#

Term, Definition table
TermDefinition
Mechanical-cutting endoscopic polypectomy snareA sterile, flexible, non-powered (i.e., not electrosurgical) device intended to be inserted through an endoscope to ensnare and cut polyps or other mucosal lesions during endoscopic surgery. It typically consists of a flexible sheath with a sharp cutting snare loop attached to the distal end of the sheath, and a handle which mechanically controls snaring through manual action. 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
00724995247317SmartBand EMR KitUS EndoscopyFDI2025-11-21
00724995247324SmartBand EMR PackUS EndoscopyFDI2025-11-21
00724995220051Roth NetUS EndoscopyFDI2024-11-25
00724995220068Roth Net PlatinumUS EndoscopyFDI2024-11-25
00724995194369CoinTipUS EndoscopyFDI2020-06-11
00724995194376CoinTipUS EndoscopyFDI2020-06-11
00724995194383CoinTipUS EndoscopyFDI2020-06-11
00724995182878HistolockUS EndoscopyFDI2020-04-02
00724995182908Roth Net PlatinumUS EndoscopyFDI2020-04-02
00724995182915Roth Net PlatinumUS EndoscopyFDI2020-04-02
00724995182922Roth Net PlatinumUS EndoscopyFDI2020-04-02
00724995182939Roth Net PlatinumUS EndoscopyFDI2020-04-02
00724995180782iSnareUS EndoscopyFDI2020-03-19
00724995180799iSnareUS EndoscopyFDI2020-03-19
00724995180805iSnareUS EndoscopyFDI2020-03-19
00724995180812iSnareUS EndoscopyFDI2020-03-19
00724995180829iSnareUS EndoscopyFDI2020-03-19
00724995182472Short ThrowUS EndoscopyFDI2020-03-19
00724995182489Short ThrowUS EndoscopyFDI2020-03-19
00724995182496Roth NetUS EndoscopyFDI2020-03-19
00724995182502Roth NetUS EndoscopyFDI2020-03-19
00724995182519Roth NetUS EndoscopyFDI2020-03-19
00724995182526Roth NetUS EndoscopyFDI2020-03-19
00724995182533Roth NetUS EndoscopyFDI2020-03-19
00724995182571LariatUS EndoscopyFDI2020-03-19
00724995182588LariatUS EndoscopyFDI2020-03-19
00724995182595Short ThrowUS EndoscopyFDI2020-03-19
00724995182601TraxtionUS EndoscopyFDI2020-03-19
00724995182625HistolockUS EndoscopyFDI2020-03-19
00724995182632LariatUS EndoscopyFDI2020-03-19