FDA.report

SEPLOU

Primary DI
06976358503866
Brand
SEPLOU
Company
SEPLOU (ZHUHAI) CO.,LTD.
Model
DIS8000
Device description
The image processor is used with the specified endoscope designed by SEPLOU during minimally invasive surgery.
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
false
Single use
false

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
06976358503866PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
06976358503866069763585038666976358503866

GMDN Terms

TermDefinition
Endoscopic video image processing unitAn electrically-powered device designed to receive and process the electronic signals sent from a video endoscope or endoscopic video camera; it does not include the endoscope nor light source and is not designed to control the endoscope. It may have additional features which compensate for/enhance the colour and light qualities provided. The resulting picture images are sent to and shown on a visual display unit (VDU), typically to assist the endoscope operator with an ongoing intervention and often to allow the patient visualization of the process; the images can be recorded on a video recorder or stored on computerized media.

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
true
Expiration date on label
false
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
06976358502173SEPLOUURS30052025-09-17
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

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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
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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
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