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Saneso SAN360G-A

by Saneso, Inc.

Saneso SAN360G-A is a flexible video gastroscope (FDA Class II; FDA product code FDS, Gastroscope And Accessories, Flexible/Rigid) made by Saneso, Inc., cleared under FDA 510(k) K210052 on 1 Apr 2022 and listed in FDA GUDID since 4 Nov 2022 (UDI-DI G347SAN360GA0), 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 NumberG347SAN360GA0 UDI-DI Date4 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 G347SAN360GA0 listed 4 Nov 2022 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K210052
  2. Listed FDA GUDID G347SAN360GA0

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  • Withdrawn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
Flexible video gastroscope, reusable
Model / reference
SAN360G-A
Primary DI / UDI-DI
G347SAN360GA0
510(k) Number
FDA product code
FDS
GMDN term
Flexible video gastroscope, reusable
Device class
Class II
Regulation number
876.1500
GUDID distribution status
In Commercial Distribution
Size
Length — 1040 Millimeter
Outer Diameter — 15.6 Millimeter

Related devices

Category: Flexible video gastroscope, reusable

Cleared under the same submission (K210052)

Similar devices

Other devices filed under FDA product code FDS (Gastroscope And Accessories, Flexible/Rigid).

Other devices from Saneso, Inc.

  • Saneso SAN1C-A

    Class II

  • Saneso SAN1G-A

    Class II

  • Saneso SAN360C-A

    Class II

  • Saneso G347SBA

    Class II

See all devices from Saneso, Inc. →

Properties

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