LUMINELLE DTx System

510(k) Number

K210512 ↗

FDA product code

FAJ

Device class

Class II

Regulation

21 CFR Part 876.1500

Advisory committee

Gastroenterology, Urology

FDA decision

SESE Substantially Equivalent

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Source: 510k-lineage (choiben314), CC BY 4.0

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Other devices filed under FDA product code FAJ (Cystoscope And Accessories, Flexible/Rigid).

• KARL STORZ TELESCOPE BRIDGES AND ADAPTERS by Karl Storz Endoscopy-America, Inc.
• Uro-V Cystoscope by UroViu Corporation
• VIPER 7325076 7325.076 by Richard Wolf GmbH
• aScope 5 Cysto HD (Standard Deflection); aScope 5 Cysto HD (Reverse Deflection); aView 2 Advance by Ambu A/S
• NTECH CYSTOSCOPES by N-Tech Endoscopy, Inc.
• STRYKER FLEXIBLE CYSTONEPHROSCOPE by Stryker Endoscopy
• Endo SmartCap 100164CO2EXT by MEDIVATORS INC.
• FLEXIBLE CYSTOSCOPE by Applied Fiberoptics, Inc.
• HOPKINS 27020BA by Karl Storz SE & CO. KG
• Karl Storz Hopkins Telescopes for Urology by Karl Storz SE & CO. KG

• Uvision Hysteroscope Cable 20050

  Class II

  FDA 510(k) K181909 Active Cleared 16 Aug 2018 GUDID on market

• LUMINELLE DTx 360 Rotatable Disposable Sheaths LUMDTx-360

  Class II

  FDA 510(k) K181909 Active Cleared 16 Aug 2018 GUDID on market

• LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy) LUMBx-360 DOWN

  Class II

  FDA 510(k) K210512 Active Cleared 30 Jun 2021 GUDID on market

• LUMINELLE Aspirator LUM-A

  Class I

  GUDID on market

See all devices from Uvision360, Inc. →