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F88 0503388001

by Sg Endoscopy Pte, Ltd.

F88 0503388001 is an endoscope working-channel valve (FDA Class II; FDA product code FGB, Ureteroscope And Accessories, Flexible/Rigid) made by Sg Endoscopy Pte, Ltd., cleared under FDA 510(k) K243894 on 2 May 2025 and listed in FDA GUDID since 30 Jun 2025 (UDI-DI 08881300750107), 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) K243894

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 Number08881300750107 UDI-DI Date30 Jun 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK243894 Date2 May 2025DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K243894 decided 2 May 2025 Active
  • FDA GUDID UDI-DI 08881300750107 listed 30 Jun 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K243894
  2. Listed FDA GUDID 08881300750107

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
F88
Generic name
Endoscope working-channel valve, reusable
Model / Ref / Catalog
0503388001
Primary DI / UDI-DI
08881300750107
510(k) Number
FDA product code
FGB
GMDN term
Endoscope working-channel valve, reusable
Device class
Class II
Regulation number
876.1500
GUDID distribution status
In Commercial Distribution
Sterilisation method
Hydrogen Peroxide

Related devices

Category: Endoscope working-channel valve, reusable

Cleared under the same submission (K243894)

and 1 more cleared under K243894

Similar devices

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

Other devices from Sg Endoscopy Pte, Ltd.

  • F88 0228388000

    Class II

  • F88 0502388100

    Class II

  • F88 0502388110

    Class II

  • F88 0503388008

    Class II

See all devices from Sg Endoscopy Pte, Ltd. →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (11, all answered No)