FDA.reportPublic FDA data

Single-use Ureteral Access Sheath

Primary DI
06972197482249
Brand
Single-use Ureteral Access Sheath
Company
Hunan Vathin Medical Instrument Co., Ltd
Model
UA-S1A00
Published
2024-11-04
Public version status
Update
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
FEDEndoscopic Access Overtube, Gastroenterology-Urology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FEDEndoscopic Access Overtube, Gastroenterology-UrologyGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K240167000
K250785000
K251599000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240167000Single-use Ureteral Access SheathHunan Vathin Medical Instrument Co., Ltd.2024-10-08FED
K250785000Single-use Flexible UreteroscopeHunan Vathin Medical Instrument Co., Ltd.2025-05-06FGB
K251599000Single-use Ureteral Access SheathHunan Vathin Medical Instrument Co., Ltd.2025-07-03FED

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16972197482246PackageGS11In Commercial Distribution
56972197482244PackageGS110In Commercial Distribution
06972197482249PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697219748224616972197482246
5697219748224456972197482244
06972197482249069721974822496972197482249

GMDN Terms#

Term, Definition table
TermDefinition
Ureteral introduction sheathA flexible tube intended to be used for ureteral access to allow introduction of other instruments (e.g., endoscope, catheter) and/or for guidewire exchange during a urological procedure. It may be intended for ureteral access via transurethral and/or percutaneous approach, and typically includes an inner dilator; it is however not a full introduction set. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
554484862
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06972197483420Single-use Ureteral Access SheathUA-S18022025-08-08
06972197483437Single-use Ureteral Access SheathUA-S18032025-08-08
06972197483444Single-use Ureteral Access SheathUA-S1A022025-08-08
06972197483451Single-use Ureteral Access SheathUA-S1A032025-08-08
06972197483468Single-use Ureteral Access SheathUA-S1B022025-08-08
06972197483475Single-use Ureteral Access SheathUA-S1B032025-08-08
06972197483482Single-use Ureteral Access SheathUA-S1C022025-08-08
06972197483499Single-use Ureteral Access SheathUA-S1C032025-08-08
06972197483505Single-use Ureteral Access SheathUA-S1D022025-08-08
06972197483512Single-use Ureteral Access SheathUA-S1D032025-08-08
06972197482225Single-use Ureteral Access SheathUA-S18002024-11-04
06972197482232Single-use Ureteral Access SheathUA-S18012024-11-04
06972197482256Single-use Ureteral Access SheathUA-S1A012024-11-04
06972197482263Single-use Ureteral Access SheathUA-S1B002024-11-04
06972197482270Single-use Ureteral Access SheathUA-S1B012024-11-04
06972197482287Single-use Ureteral Access SheathUA-S1C002024-11-04
06972197482294Single-use Ureteral Access SheathUA-S1C012024-11-04
06972197482300Single-use Ureteral Access SheathUA-S1D002024-11-04
06972197482317Single-use Ureteral Access SheathUA-S1D012024-11-04
06972197480405Single-Use Flexible RhinolaryngoscopeRL-E18002023-02-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06936345101536Disposable Ureteral Guide SheathDongguan ZSR Biomedical Technology Company LimitedFED2026-05-27
06936345101543Disposable Ureteral Guide SheathDongguan ZSR Biomedical Technology Company LimitedFED2026-05-27
06936345104469Disposable Ureteral Guide SheathDongguan ZSR Biomedical Technology Company LimitedFED2026-05-27
06936345104476Disposable Ureteral Guide SheathDongguan ZSR Biomedical Technology Company LimitedFED2026-05-27
06936345104483Disposable Ureteral Guide SheathDongguan ZSR Biomedical Technology Company LimitedFED2026-05-27
06936345104490Disposable Ureteral Guide SheathDongguan ZSR Biomedical Technology Company LimitedFED2026-05-27
06936345104544Disposable Ureteral Guide SheathDongguan ZSR Biomedical Technology Company LimitedFED2026-05-27
06936345104551Disposable Ureteral Guide SheathDongguan ZSR Biomedical Technology Company LimitedFED2026-05-27
06936345104568Disposable Ureteral Guide SheathDongguan ZSR Biomedical Technology Company LimitedFED2026-05-27
06936345104575Disposable Ureteral Guide SheathDongguan ZSR Biomedical Technology Company LimitedFED2026-05-27
06925816667213ClearPetraWell Lead Medical Co.,LtdFED2026-03-16
06925816667220ClearPetraWell Lead Medical Co.,LtdFED2026-03-16
06925816667237ClearPetraWell Lead Medical Co.,LtdFED2026-03-16
06925816657511ClearPetraWell Lead Medical Co.,LtdFED2026-01-26
06925816657528ClearPetraWell Lead Medical Co.,LtdFED2026-01-26
06925816657535ClearPetraWell Lead Medical Co.,LtdFED2026-01-26
06925816657542ClearPetraWell Lead Medical Co.,LtdFED2026-01-26
06925816657559ClearPetraWell Lead Medical Co.,LtdFED2026-01-26
06925816657566ClearPetraWell Lead Medical Co.,LtdFED2026-01-26
06925816657573ClearPetraWell Lead Medical Co.,LtdFED2026-01-26
06925816657580ClearPetraWell Lead Medical Co.,LtdFED2026-01-26
06925816657597ClearPetraWell Lead Medical Co.,LtdFED2026-01-26
06925816657603ClearPetraWell Lead Medical Co.,LtdFED2026-01-26
06925816657610ClearPetraWell Lead Medical Co.,LtdFED2026-01-26
06925816657627ClearPetraWell Lead Medical Co.,LtdFED2026-01-26
06925816657634ClearPetraWell Lead Medical Co.,LtdFED2026-01-26
06925816657641ClearPetraWell Lead Medical Co.,LtdFED2026-01-26
06925816657658ClearPetraWell Lead Medical Co.,LtdFED2026-01-26
06925816657665ClearPetraWell Lead Medical Co.,LtdFED2026-01-26
06925816657672ClearPetraWell Lead Medical Co.,LtdFED2026-01-26