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VS3-Ne 443-0001

by Visionsense Ltd. 6 variants

VS3-Ne 443-0001 is a Class II device made by Visionsense Ltd., cleared under FDA 510(k) K131434 on 16 Jul 2013 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 18130400103373), 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) K131434

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 Number18130400103373 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK131434 Date16 Jul 2013DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K131434 decided 16 Jul 2013 Active
  • FDA GUDID UDI-DI 18130400103373 listed 23 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K131434
  2. Listed FDA GUDID 18130400103373

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
VS3-Ne
Generic name
Endoscope video camera
Model / Ref / Catalog
443-0001
Primary DI / UDI-DI
18130400103373
510(k) Number
FDA product code
GWG
GMDN term
Endoscope video camera
Device class
Class II
Regulation number
882.1480
GUDID distribution status
In Commercial Distribution

Related devices

Category: Endoscope video camera

Cleared under the same submission (K131434)

Similar devices in this category

Other devices filed under Endoscope video camera.

Other devices from Visionsense Ltd.

See all devices from Visionsense Ltd. →

Properties

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