ZKSK

Primary DI
06934415024174
Brand
ZKSK
Company
Beijing ZKSK Technology Co.,Ltd
Model
ECK18-25-10-180
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
06934415024174PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06934415024174069344150241746934415024174

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
06934415023009ZKSKBF19-DP23-23002026-09-24
06934415023467ZKSKBF19-DC23-23002026-09-24
06934415023474ZKSKBF19-FP23-23002026-09-24
06934415024785ZKSKBF19-AP23-3002026-09-24
06934415024792ZKSKBF19-AP23-5002026-09-24
06934415024808ZKSKBF19-AP23-6002026-09-24
06934415024815ZKSKBF19-AP23-8002026-09-24
06934415024822ZKSKBF19-AP23-10502026-09-24
06934415024839ZKSKBF19-AP23-12002026-09-24
06934415024846ZKSKBF19-AP23-16002026-09-24
06934415024853ZKSKBF19-AP23-18002026-09-24
06934415024860ZKSKBF19-AP23-20002026-09-24
06934415024877ZKSKBF19-AP23-23002026-09-24
06934415024884ZKSKBF19-BP23-3002026-09-24
06934415024891ZKSKBF19-BP23-5002026-09-24
06934415024907ZKSKBF19-BP23-6002026-09-24
06934415024914ZKSKBF19-BP23-8002026-09-24
06934415024921ZKSKBF19-BP23-10502026-09-24
06934415024938ZKSKBF19-BP23-12002026-09-24
06934415024945ZKSKBF19-BP23-16002026-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
06959664912102NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664912119NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664919118NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664934036NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664934067NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664934074NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664934098NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17