Medisono END-VYS EC-P550ST Colonoscope

• FDA 510(k) K211882 decided 1 Apr 2022 Active
• FDA GUDID UDI-DI B369MES01034 listed 17 Nov 2023 Listed

1. 1 Apr 2022 Cleared FDA 510(k) K211882
2. 17 Nov 2023 Listed FDA GUDID B369MES01034

Trade name

Medisono

Generic name

Flexible fibreoptic colonoscope

Model / Ref / Catalog

Medisono END-VYS EC-P550ST Colonoscope, MES01034

Primary DI / UDI-DI

B369MES01034

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).

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• UPD-Y0003 by Olympus Medical Systems Corporation
• Zutron Colonoscope Stiffening Device by Zutron Medical, LLC
• Navigator Endoscopy System by Neoguide Systems, Inc.
• Evis Exera Colonovideoscope Model XCF-Q160W1L/1 by Aizu Olympus Co., Ltd.
• Pentax Medical Video Colonoscope EC34-i10T Series by PENTAX of America, Inc.
• PENTAX Video Colonoscopes (EC Family) by PENTAX of America Inc.
• Vision System Colonscope by Vision-Sciences, Inc.
• INVENDO C20 COLONOSCOPY SYSTEM by Invendo Medical Gbmh
• Naviaid Balloon Guided Colonoscopy (BGC) Device by SMART MEDICAL SYSTEMS LTD

• Medisono END-VYS EG-500L Gastroscope

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• Medisono END-VYS X-2200Pro System

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• Medisono END-VYS HDL-35E Light Source

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• Medisono

  Class II

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

See all devices from Medisono, LLC →