Skip to content

Saneso G347SBA

by Saneso, Inc.

Saneso G347SBA is an endoscopic control/video-imaging system (FDA Class II; FDA product code FET, Endoscopic Video Imaging System/Component, Gastroenterology-Urology) made by Saneso, Inc., cleared under FDA 510(k) K210052 on 1 Apr 2022 and listed in FDA GUDID since 11 Nov 2022 (UDI-DI G347SBA0), 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) K210052

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 NumberG347SBA0 UDI-DI Date11 Nov 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK210052 Date1 Apr 2022DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K210052 decided 1 Apr 2022 Active
  • FDA GUDID UDI-DI G347SBA0 listed 11 Nov 2022 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K210052
  2. Listed FDA GUDID G347SBA0

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Saneso
Generic name
Endoscopic control/video-imaging system
Model / reference
G347SBA
Primary DI / UDI-DI
G347SBA0
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 (K210052)

Similar devices

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

Other devices from Saneso, Inc.

  • Saneso SAN360G-A

    Class II

  • Saneso SAN1C-A

    Class II

  • Saneso SAN1G-A

    Class II

  • Saneso SAN360C-A

    Class II

See all devices from Saneso, Inc. →

Properties

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