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Ev-001

by Konan Medical USA, Inc.

Ev-001 is a Class II device made by Konan Medical USA, Inc., cleared under FDA 510(k) K081591 on 15 May 2009 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 04582275270020), 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) K081591

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 Number04582275270020 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK081591 Date15 May 2009DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K081591 decided 15 May 2009 Active
  • FDA GUDID UDI-DI 04582275270020 listed 23 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K081591
  2. Listed FDA GUDID 04582275270020

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Vision electrophysiology analysis system
Model / reference
EV-001
Primary DI / UDI-DI
04582275270020
510(k) Number
FDA product code
GWE
GMDN term
Vision electrophysiology analysis system
Device class
Class II
Regulation number
882.1890
GUDID distribution status
In Commercial Distribution

Related devices

Category: Vision electrophysiology analysis system

Similar devices

Other devices filed under FDA product code GWE (Stimulator, photic, evoked response).

Other devices from Konan Medical USA, Inc.

See all devices from Konan Medical USA, Inc. →

Properties

  • Lot / batch number
  • Serial number
Other properties (13, all answered No)