FDA.reportPublic FDA data

Stone Extraction Balloon

Primary DI
06970057571027
Brand
Stone Extraction Balloon
Company
Jiangsu Vedkang Medical Science and Technology Co.,Ltd.
Model
VDK-BAL-23-11/13/15-B
Published
2026-04-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GCABiliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCABiliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast InjectionGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K232752000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232752000Stone Extraction Balloon (VDK-BAL-23-11/13/15-B,VDK-BAL-23-15/18/20-B,VDK-BAL-23-9/12/15-B,VDK-BAL-23-10/13/16-B,VDK-BAL-23-8.5/11.5/15-B,VDK-BAL-23-12/15/18-B,VDK-BAL-23-11/13/15-C,VDK-BAL-23-15/18/20-C,VDK-BAL-23-9/12/15-C,VDK-BAL-23-10/13/16-C,VDK-BAL-23-8.5/11.5/15-C,VDK-BAL-23-12/15/18-C)Jiangsu Vedkang Medical Science and Technology Co., Ltd.2024-02-26GCA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
26970057571021PackageGS12In Commercial Distribution
56970057571022PackageGS120In Commercial Distribution
06970057571027PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2697005757102126970057571021
5697005757102256970057571022
06970057571027069700575710276970057571027

GMDN Terms#

Term, Definition table
TermDefinition
ERCP catheter, balloon, non-electrical, stone-retrievalA flexible, tubular, non-electrical device with an inflatable multi-sizing balloon at the distal end designed for the removal of stones (calculi) from the biliary tract during endoscopic retrograde cholangiopancreatography (ERCP). It is inserted through the working channel of an endoscope, typically beyond the stones, where the balloon is inflated and retracted to push the stones out. It typically has more than one lumen to allow, e.g., use of a guidewire while simultaneously enabling the injection of a contrast medium into the biliary tree for fluoroscopic visualization of the bile ducts. This is a single-use device.

Regulatory Flags#

DUNS number
544430136
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06941513200089Disposable Non-electric Biopsy ForcepsVDK-FB-30-230-O-P1-B12026-05-22
06941513222692Disposable Non-electric Biopsy ForcepsVDK-FB-23-230-O-P-A22026-05-22
06941513222708Disposable Non-electric Biopsy ForcepsVDK-FB-23-230-O-P1-A22026-05-22
06941513222715Disposable Non-electric Biopsy ForcepsVDK-FB-23-230-W-P-A22026-05-22
06941513222722Disposable Non-electric Biopsy ForcepsVDK-FB-23-230-W-P1-A22026-05-22
06970057578248Disposable Cleaning BrushVDK-CB-06-230-C2026-05-22
06970057578286Polyp TrapsVDK-PT-052026-05-22
06970057579023Disposable Grasping ForcepsVDK-FG-23-230-A12026-05-22
06970057577937Disposable SphincterotomeVDK-KE-3025110-A2026-04-14
06970057579061Disposable Grasping ForcepsVDK-FG-23-230-A42026-03-25
06970057573014VedBasket, Stone Extraction BasketsVDK-BAS-23-200-30-S4-A2024-08-20
06970057575032Disposable Polyp SnareVDK-SD-23-230-35-A12024-08-20
06970057578040Disposable Endoscopic HemoclipVDK-CD-13-230-P2024-08-20
06970057578118Disposable Endoscopic HemoclipVDK-CD-16-230-P2024-08-20
06970057573021VedBasket, Stone Extraction BasketsVDK-BAS-23-200-35-S4-A2024-08-20
06970057578002Disposable Endoscopic HemoclipVDK-CD-11-230-P2024-08-20
06970057574486Disposable Non-electric Biopsy ForcepsVDK-FB-23-230-W-P1-A12025-05-19
16970057574483Disposable Non-electric Biopsy ForcepsVDK-FB-23-230-W-P1-A12025-05-19
06941513210972Disposable Non-electric Biopsy ForcepsVDK-FB-18-70-O-P-B12025-02-26
06970057579184Disposable Grasping ForcepsVDK-FG-18-70-A42025-02-26

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