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EvoEndo Controller EE-C

by Evoendo, Inc.

EvoEndo Controller EE-C (1002) is an endoscopic control/video-imaging system (FDA Class II; FDA product code FET, Endoscopic Video Imaging System/Component, Gastroenterology-Urology) made by Evoendo, Inc., cleared under FDA 510(k) K213606 on 14 Feb 2022 and listed in FDA GUDID since 25 Feb 2022 (UDI-DI 00850031897021), active as of 22 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 22 Oct 2026

Documents

510(k) K213606

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850031897021 UDI-DI Date25 Feb 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK213606 Date14 Feb 2022DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K213606 decided 14 Feb 2022 Active
  • FDA GUDID UDI-DI 00850031897021 listed 25 Feb 2022 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K213606
  2. Listed FDA GUDID 00850031897021

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
EvoEndo Controller
Generic name
Endoscopic control/video-imaging system
Model / Ref / Catalog
EE-C, 1002
Primary DI / UDI-DI
00850031897021
510(k) Number
FDA product code
FET
GMDN term
Endoscopic control/video-imaging system
Device class
Class II
Regulation number
876.1500
GUDID distribution status
In Commercial Distribution

Related devices

Category: Endoscopic control/video-imaging system

Cleared under the same submission (K213606)

and 1 more cleared under K213606

Similar devices

Other devices filed under FDA product code FET (Endoscopic Video Imaging System/Component, Gastroenterology-Urology).

Other devices from Evoendo, Inc.

See all devices from Evoendo, Inc. →

Properties

  • Serial number
Other properties (14, all answered No)