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Medisono END-VYS EG-500 Gastroscope

by Medisono, LLC

Medisono END-VYS EG-500 Gastroscope (MES01013) is a Class II device made by Medisono, LLC, cleared under FDA 510(k) K211882 on 1 Apr 2022 and listed in FDA GUDID since 17 Nov 2023 (UDI-DI B369MES01013), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K211882

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberB369MES01013 UDI-DI Date17 Nov 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK211882 Date1 Apr 2022DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K211882 decided 1 Apr 2022 Active
  • FDA GUDID UDI-DI B369MES01013 listed 17 Nov 2023 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K211882
  2. Listed FDA GUDID B369MES01013

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Medisono
Generic name
Flexible fibreoptic gastroscope
Model / Ref / Catalog
Medisono END-VYS EG-500 Gastroscope, MES01013
Primary DI / UDI-DI
B369MES01013
510(k) Number
FDA product code
FDS
GMDN term
Flexible fibreoptic gastroscope
Device class
Class II
Regulation number
876.1500
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Related devices

Category: Flexible fibreoptic gastroscope

Cleared under the same submission (K211882)

and 8 more cleared under K211882

Similar devices

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

Other devices from Medisono, LLC

See all devices from Medisono, LLC →

Properties

  • Serial number
  • Manufacturing date
Other properties (13, all answered No)