Medisono END-VYS EC-550T Colonoscope

• FDA 510(k) K211882 decided 1 Apr 2022 Active
• FDA GUDID UDI-DI B369MES01028 listed 17 Nov 2023 Listed

1. 1 Apr 2022 Cleared FDA 510(k) K211882
2. 17 Nov 2023 Listed FDA GUDID B369MES01028

Trade name

Medisono

Generic name

Flexible fibreoptic colonoscope

Model / Ref / Catalog

Medisono END-VYS EC-550T Colonoscope, MES01028

Primary DI / UDI-DI

B369MES01028

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).

• THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPE SYSTEM by Avantis Medical Systems, Inc.
• ENOLOK-FOR ENDOSCOPED WITH 12.8>DIA.<13.3MM SHAFT DIAMETER, MODEL AEL; ENDOSCOPES WITH 11.3>DIA. 11.5MM SHAFT, MODEL PEL by Syntheon, LLC
• PENTAX VIDEO COLONOSCOPES (EC FAMILY) by Pentax Medical Company
• Fujifilm Video Colonoscope Model EC-600WL V2 by Fujifilm Medical System U.S.A., Inc.
• FUSE COLONOSCOPY SYSTEM by Endochoice, Inc.
• PENTEX EC-3890LI by Pentax Medical Company
• CLEARPATH LOWER GI by Easyglide, Ltd.
• INHEALTH SOFT SLEEVE COLONOSCOPE SPLINT, MODEL CS1200 by Helix Medical, Inc.
• Pure-Vu System by MOTUS GI MEDICAL TECHNOLOGIES LTD
• NEOGUIDE ENDOSCOPY SYSTEM by Neoguide Systems, Inc.

• 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 →