Medisono END-VYS EC-500L/T Colonoscope

• FDA 510(k) K211882 decided 1 Apr 2022 Active
• FDA GUDID UDI-DI B369MES01026 listed 17 Nov 2023 Listed

1. 1 Apr 2022 Cleared FDA 510(k) K211882
2. 17 Nov 2023 Listed FDA GUDID B369MES01026

Trade name

Medisono

Generic name

Flexible fibreoptic colonoscope

Model / Ref / Catalog

Medisono END-VYS EC-500L/T Colonoscope, MES01026

Primary DI / UDI-DI

B369MES01026

510(k) Number

K211882 ↗

FDA product code

FDF

GMDN term

Flexible fibreoptic colonoscope

Device class

Class II

Regulation number

876.1500

GUDID distribution status

In Commercial Distribution

MRI safety

MR Unsafe

Category: Flexible fibreoptic colonoscope

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

• CONTAINER PROTECTOR MAJ-905 by Olympus Medical Systems Corporation
• FUJIFILM Endoscope Model EC-760S-V/L by FUJIFILM CORPORATION
• Third Eye Panoramic Auxiliary Endoscopy System - Resposable by Avantis Medical Systems, Inc.
• Pure-Vu EVS System by MOTUS GI MEDICAL TECHNOLOGIES LTD
• EUS BALLOON by United States Endoscopy Group, Inc.
• GASTROSCOPE AND COLONOSCOPE NOZZLE REPLACEMENT KITS by Precision Endoscopy of America, Inc.
• THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPY SYSTEM by Avantis Medical Systems, Inc.
• Aer-O-Scope Colonoscope System by Gi View, Ltd.
• COLONOSCOPE/SIGMOIDOSCOPE SHEATHES by Sheathing Technologies, Inc.
• Flex Robotic System and Flex Colorectal Drive by Medrobotics Corporation

• Medisono END-VYS EC-P550ST Colonoscope

  Class II

  FDA 510(k) K211882 Active Cleared 1 Apr 2022 GUDID on market

• Medisono END-VYS EG-500L Gastroscope

  Class II

  FDA 510(k) K211882 Active Cleared 1 Apr 2022 GUDID on market

• Medisono END-VYS X-2200Pro System

  Class II

  FDA 510(k) K211882 Active Cleared 1 Apr 2022 GUDID on market

• Medisono END-VYS HDL-35E Light Source

  Class II

  FDA 510(k) K211882 Active Cleared 1 Apr 2022 GUDID on market

See all devices from Medisono, LLC →