FDA.report

SEPLOU

Primary DI
06976358502173
Brand
SEPLOU
Company
SEPLOU (ZHUHAI) CO.,LTD.
Model
URS3005
Device description
The Medical Video Endoscope is designed to be used with endo-therapy accessories such as a biopsy forceps and other ancillary equipment for endoscopy and endoscopic surgery within urinary tract and interior of the kidney.
Published
2025-09-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
FGBUreteroscope And Accessories, Flexible/Rigid

Product Code Classifications

CodeDeviceSpecialtyClass
FGBUreteroscope And Accessories, Flexible/RigidGastroenterology, Urology2

Premarket Submissions

SubmissionSupplement
K250049000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K250049000Medical Video Endoscope [Standard Deflection] (URS3005); Medical Video Endoscope [Reverse Deflection] (URS3005E); Medical Video Endoscope [Standard Deflection] (URS3006); Medical Video Endoscope [Reverse Deflection] (URS3006E); Medical Video Endoscope [Standard Deflection] (URS3016); Medical Video Endoscope [Reverse Deflection] (URS3016E); Image processor (DIS8000)Seplou (Zhuhai) Co., Ltd.2025-08-26FGB

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
06976358502173PrimaryGS10

Alternate GTIN/UPC/EAN values are derived from GS1 digit structure for lookup convenience. Do not treat derived UPC-A or EAN-13 values as separate FDA identifiers. GTIN-14 values with indicator digits 1-9 usually represent packaging levels, cases, pallets, or variable-measure items and are not converted to UPC-A/EAN-13 here.

Alternate GTIN / UPC / EAN Codes

Source identifierSource lengthGTIN-14 normalizedIndicatorEAN-13Conversion note
06976358502173140697635850217306976358502173Indicator 0 allows EAN-13 conversion; UPC-A requires prefix 00.

GMDN Terms

TermDefinition
Flexible video ureteroscope, single-useAn endoscope with a flexible inserted portion intended for the visual examination and treatment of the ureter (the upper urinary tract that connects the kidney to the bladder). It is inserted through the external urethral orifice and bladder during ureteroscopy. Anatomical images are typically transmitted by a video system with a high definition complementary metal oxide semiconductor (CMOS) chip at the distal end with images showing on a monitor. This device is commonly used for biopsies, endoscopic lithotripsy, treatment of upper urinary tract malignancies, incising strictures, and repairing ureteropelvic junction obstructions. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
847378548
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
false
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 DIBrandModelCatalogPublished
06976358502135SEPLOUURS30162025-09-17
06976358502142SEPLOUURS3016E2025-09-17
06976358502159SEPLOUURS30062025-09-17
06976358502166SEPLOUURS3006E2025-09-17
06976358502180SEPLOUURS3005E2025-09-17
06976358503668SEPLOUSPAS10282025-09-17
06976358503675SEPLOUSPAS10352025-09-17
06976358503682SEPLOUSPAS10452025-09-17
06976358503699SEPLOUSPAS11352025-09-17
06976358503705SEPLOUSPAS11452025-09-17
06976358503712SEPLOUSPAS12352025-09-17
06976358503729SEPLOUSPAS12452025-09-17
06976358503736SEPLOUSPAS13352025-09-17
06976358503743SEPLOUSPAS13452025-09-17
06976358503750SEPLOUSPAS14352025-09-17
06976358503767SEPLOUSPAS14452025-09-17
06976358503774SEPLOUSPAS1033S2025-09-17
06976358503781SEPLOUSPAS1040S2025-09-17
06976358503798SEPLOUSPAS1050S2025-09-17
06976358503804SEPLOUSPAS1140S2025-09-17

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
06972520301216Ascend™ Single-Use Flexible UreteroscopeGuangzhou Red Pine Medical Instrument Co., Ltd.FGB2026-03-17
06972520301223Ascend™ Single-Use Flexible UreteroscopeGuangzhou Red Pine Medical Instrument Co., Ltd.FGB2026-03-17
06972520301230Ascend™ Single-Use Flexible UreteroscopeGuangzhou Red Pine Medical Instrument Co., Ltd.FGB2026-03-17
06972520301247Ascend™ Single-Use Flexible UreteroscopeGuangzhou Red Pine Medical Instrument Co., Ltd.FGB2026-03-17
06972520301254Ascend™ Single-Use Flexible UreteroscopeGuangzhou Red Pine Medical Instrument Co., Ltd.FGB2026-03-17
06972520301261Ascend™ Single-Use Flexible UreteroscopeGuangzhou Red Pine Medical Instrument Co., Ltd.FGB2026-03-17
06972520301278Ascend™ Single-Use Flexible UreteroscopeGuangzhou Red Pine Medical Instrument Co., Ltd.FGB2026-03-17
06972520301285Ascend™ Single-Use Flexible UreteroscopeGuangzhou Red Pine Medical Instrument Co., Ltd.FGB2026-03-17
00810116023370Dornier MedTech DORNIER MEDTECH AMERICA, INC.FGB2026-01-22
00810116023417Dornier MedTechDORNIER MEDTECH AMERICA, INC.FGB2026-01-22
00810116023523Axis IIDORNIER MEDTECH AMERICA, INC.FGB2026-01-22
00810116023585Dornier MedTechDORNIER MEDTECH AMERICA, INC.FGB2026-01-22
16971176282921Single Use Video Ureteroscope Direct In-Scope SuctionZhuhai Pusen Medical Technology Co, LtdFGB2026-01-13
16971176282938Single Use Video Ureteroscope Direct In-Scope SuctionZhuhai Pusen Medical Technology Co, LtdFGB2026-01-13
06971176282948Single Use Flexible Video UreteroscopeZhuhai Pusen Medical Technology Co, LtdFGB2026-01-13
16971176282952Single Use Flexible Video UreteroscopeZhuhai Pusen Medical Technology Co, LtdFGB2026-01-13
16971176282969Single Use Video Ureteroscope Direct In-Scope SuctionZhuhai Pusen Medical Technology Co, LtdFGB2026-01-13
06971176282979Single Use Video Ureteroscope Direct In-Scope SuctionZhuhai Pusen Medical Technology Co, LtdFGB2026-01-13
16971176282983Single Use Flexible Video UreteroscopeZhuhai Pusen Medical Technology Co, LtdFGB2026-01-13
16971176282990Single Use Flexible Video UreteroscopeZhuhai Pusen Medical Technology Co, LtdFGB2026-01-13
06972520300677Endoscopic Video Image ProcessorGuangzhou Red Pine Medical Instrument Co., Ltd.FGB2025-12-31
06972520301759Single-Use Video Flexible UreterorenoscopeGuangzhou Red Pine Medical Instrument Co., Ltd.FGB2025-12-31
06972520301766Single-Use Video Flexible UreterorenoscopeGuangzhou Red Pine Medical Instrument Co., Ltd.FGB2025-12-31
06972520301773Single-Use Video Flexible UreterorenoscopeGuangzhou Red Pine Medical Instrument Co., Ltd.FGB2025-12-31
06972520301780Single-Use Video Flexible UreterorenoscopeGuangzhou Red Pine Medical Instrument Co., Ltd.FGB2025-12-31
06972520302794Ascend™ Single-Use Flexible UreteroscopeGuangzhou Red Pine Medical Instrument Co., Ltd.FGB2025-12-31
06972520302800Ascend™ Single-Use Flexible UreteroscopeGuangzhou Red Pine Medical Instrument Co., Ltd.FGB2025-12-31
06972520302817Ascend™ Single-Use Flexible UreteroscopeGuangzhou Red Pine Medical Instrument Co., Ltd.FGB2025-12-31
06972520302824Ascend™ Single-Use Flexible UreteroscopeGuangzhou Red Pine Medical Instrument Co., Ltd.FGB2025-12-31
06972520303067Endoscopic Video Image Processor HDGuangzhou Red Pine Medical Instrument Co., Ltd.FGB2025-12-31