Medisono END-VYS EC-430 Colonoscope

• FDA 510(k) K211882 decided 1 Apr 2022 Active
• FDA GUDID UDI-DI B369MES01019 listed 17 Nov 2023 Listed

1. 1 Apr 2022 Cleared FDA 510(k) K211882
2. 17 Nov 2023 Listed FDA GUDID B369MES01019

Trade name

Medisono

Generic name

Flexible fibreoptic colonoscope

Model / Ref / Catalog

Medisono END-VYS EC-430 Colonoscope, MES01019

Primary DI / UDI-DI

B369MES01019

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).

• PENTAX Medical OE-C29 by HOYA CORPORATION
• CONNECTION UNIT MAJ-1928 by Olympus Medical Systems Corporation
• COLONOSCOPE, MODEL SC-4 FLEXIBLE FIBER by American Optical Corp.
• White cap set MAJ-941 by Olympus Medical Systems Corporation
• PENTAX FC-38LA & FC-38SA COLONOFIBER by Pentax Precision Instrument Corp.
• FUJIFILM 600 SERIES ENDOSCOPES by Fujifilm Medical System U.S.A., Inc.
• Focus Cap by Gce Medical Corporation
• GF-UE160-AL5 ULTRASOUND ENDOSCOPE by Olympus America, Inc.
• DiLumen C2 Tool Mount by LUMENDI LLC
• EC-3800L Video Colonoscope by Pentax Precision Instrument Corp.

• 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 →