FDA.reportPublic FDA data

Proxiva

Primary DI
06973356551691
Brand
Proxiva
Company
Shenzhen Trious Medical Technology Co., Ltd
Model
205W11F40
Catalog number
231140S
Device description
Proxiva™ FANS Ureteral Access Sheath, 11 Fr., 40 cm
Published
2026-08-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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
K243710000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243710000Disposable ureteral access sheathShenzhen Trious Medical Technology Co., Ltd.2025-04-11FED

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06973356551691PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06973356551691069733565516916973356551691

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic-access dilator, single-useA device intended to be used to dilate a body lumen or access channel to facilitate the introduction of endoscopic instruments percutaneously (through the skin) or through a natural orifice (e.g., urethra). It may be a flexible or rigid rod/tube with a tapered distal tip. This is a single-use device.

Regulatory Flags#

DUNS number
698045520
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06973356551455Proxiva104F15023150SC2026-08-18
06973356551462Proxiva205W14F50231450S2026-08-18
06973356551479Proxiva205W14F40231440S2026-08-18
06973356551493Proxiva205W13F50231350S2026-08-18
06973356551509Proxiva205W13F40231340S2026-08-18
06973356551660Proxiva205W12F50231250S2026-08-18
06973356551677Proxiva205W12F40231240S2026-08-18
06973356551684Proxiva205W11F50231150S2026-08-18
06973356551707Proxiva205W10F50231050S2026-08-18
06973356551714Proxiva205W10F40231040S2026-08-18
06973356551721Trious104F150SCB-TR-1502026-06-23
06973356551738Trious205W12F50FANS-12-5002026-06-23
06973356551745Trious205W12F40FANS-12-4002026-06-23
06973356551752Trious205W11F50FANS-11-5002026-06-23
06973356551769Trious205W11F40FANS-11-4002026-06-23
06973356551776Trious205W10F50FANS-10-5002026-06-23
06973356551783Trious205W10F40FANS-10-4002026-06-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06973356551462ProxivaShenzhen Trious Medical Technology Co., LtdFED2026-08-18
06973356551479ProxivaShenzhen Trious Medical Technology Co., LtdFED2026-08-18
06973356551493ProxivaShenzhen Trious Medical Technology Co., LtdFED2026-08-18
06973356551509ProxivaShenzhen Trious Medical Technology Co., LtdFED2026-08-18
06973356551660ProxivaShenzhen Trious Medical Technology Co., LtdFED2026-08-18
06973356551677ProxivaShenzhen Trious Medical Technology Co., LtdFED2026-08-18
06973356551684ProxivaShenzhen Trious Medical Technology Co., LtdFED2026-08-18
06973356551707ProxivaShenzhen Trious Medical Technology Co., LtdFED2026-08-18
06973356551714ProxivaShenzhen Trious Medical Technology Co., LtdFED2026-08-18
06973356551738TriousShenzhen Trious Medical Technology Co., LtdFED2026-06-23
06973356551745TriousShenzhen Trious Medical Technology Co., LtdFED2026-06-23
06973356551752TriousShenzhen Trious Medical Technology Co., LtdFED2026-06-23
06973356551769TriousShenzhen Trious Medical Technology Co., LtdFED2026-06-23
06973356551776TriousShenzhen Trious Medical Technology Co., LtdFED2026-06-23
06973356551783TriousShenzhen Trious Medical Technology Co., LtdFED2026-06-23
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
06970462547457Single-use Ureteral Access SheathShenzhen HugeMed Medical Technical Development Co., Ltd.FED2026-02-10
06970462547464Single-use Ureteral Access SheathShenzhen HugeMed Medical Technical Development Co., Ltd.FED2026-02-10
06970462547471Single-use Ureteral Access SheathShenzhen HugeMed Medical Technical Development Co., Ltd.FED2026-02-10
06970462547488Single-use Ureteral Access SheathShenzhen HugeMed Medical Technical Development Co., Ltd.FED2026-02-10
06970462547495Single-use Ureteral Access SheathShenzhen HugeMed Medical Technical Development Co., Ltd.FED2026-02-10