Medisono END-VYS EC-430L/T Colonoscope
Medisono END-VYS EC-430L/T Colonoscope (MES01022) 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 B369MES01022), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberB369MES01022 | Date17 Nov 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK211882 | Date1 Apr 2022 | StatusActive |
Official records
- FDA 510(k) database K211882
Across registries
- FDA 510(k) K211882 decided 1 Apr 2022 Active
- FDA GUDID UDI-DI B369MES01022 listed 17 Nov 2023 Listed
Timeline
- Cleared FDA 510(k) K211882
- Listed FDA GUDID B369MES01022
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Medisono
- Generic name
- Flexible fibreoptic colonoscope
- Model / Ref / Catalog
- Medisono END-VYS EC-430L/T Colonoscope, MES01022
- Primary DI / UDI-DI
- B369MES01022
- 510(k) Number
- 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
Similar devices
Other devices filed under FDA product code FDF (Colonoscope And Accessories, Flexible/Rigid).
- FC-38LX Fiber Colonoscope by Pentax Precision Instrument Corp.
- Aer-O-Scope Colonoscope System by Gi View, Ltd.
- Fujifilm Endoscope Models EC-600HL and EC-600LS by Fujifilm Medical System U.S.A., Inc.
- Medrobotics Flex Robotic System by Medrobotics Corporation
- FC-38TLH, FIBER COLONOSCOPE by Pentax Precision Instrument Corp.
- PEERSCOPE SYSTEM by Peermedical, Ltd.
- Ambu® aScope™ Colon; Ambu® aBox™ 2 by Ambu A/S
- White cap MH-155 by Olympus Medical Systems Corporation
- GripTract-GI Endoscopic Tissue Manipulator by ACTUATED MEDICAL, INC.
- Saneso Colonoscope 360-A (Model: with/without Select Band Imaging (SBI) and with/without Dual Band Imaging(DBI)), Saneso Single Camera Colonoscope-A (Model: with/without Select Band Imaging (SBI)), Saneso Gastroscope 360-A (Model: with/without Select Band Imaging (SBI) and with/without Dual Band Imaging(DBI)), Saneso Single Camera Gastroscope-A (Model: with/without Select Band Imaging (SBI)) by Saneso, Inc.