FDA.reportPublic FDA data

ZKSK

Primary DI
06934415024532
Brand
ZKSK
Company
Beijing ZKSK Technology Co.,Ltd
Model
ECK19-25-15-180
Device description
Disposable Sphincterotome
Published
2026-05-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KNSUnit, Electrosurgical, Endoscopic (With Or Without Accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNSUnit, Electrosurgical, Endoscopic (With Or Without Accessories)Gastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K242192000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242192000Disposable SphincterotomeBeijing Zksk Technology Co., Ltd.2025-02-06KNS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06934415024532PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06934415024532069344150245326934415024532

GMDN Terms#

Term, Definition table
TermDefinition
ERCP catheter, non-balloon, electrosurgicalA flexible, tubular device designed to be inserted into the duodenum via the oral cavity (cannulation) using a flexible endoscope to: 1) infuse contrast media; and 2) deliver electrosurgical current in a monopolar configuration to cut the major duodenal papilla (papillotomy) and approximate tissues, during endoscopic retrograde cholangiopancreatography (ERCP). It includes proximal controls, a distal monopolar electrosurgical cutting wire and an inner lumen(s); it does not incorporate a balloon. This is a single-use device.

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
05060359561404Speedboat Ultraslim LongCREO MEDICAL LIMITEDKNS2026-10-01
05060359561442Speedboat UltraSlim ShortCREO MEDICAL LIMITEDKNS2026-10-01
05060359561480Speedboat Notch LongCREO MEDICAL LIMITEDKNS2026-10-01
05060359561527Speedboat Notch ShortCREO MEDICAL LIMITEDKNS2026-10-01
05060359561565SpydrBlade FlexCREO MEDICAL LIMITEDKNS2026-10-01
05060359561602FootswitchCREO MEDICAL LIMITEDKNS2026-10-01
05060359561626Reusable Interface Cable, 1.5 mCREO MEDICAL LIMITEDKNS2026-10-01
06959664901069NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664901076NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664901595NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664901663NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664901687NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664901700NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664901717NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664902646NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664903520NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664910498NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664910559NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664910566NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664910597NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664910764NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664911921NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664911976NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664911983NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664911990NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664912041NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664912065NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664912072NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664912089NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664912096NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17