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Flex-X 11278VSE

by Karl Storz SE & CO. KG

Flex-X 11278VSE is a flexible video ureterorenoscope (FDA Class II; FDA product code FGB, Ureteroscope and accessories, flexible/rigid) made by Karl Storz SE & CO. KG, listed in FDA GUDID since 11 Jan 2020 (UDI-DI 04048551416976), registry data as of 22 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04048551416976 UDI-DI Date11 Jan 2020ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
Flex-X
Generic name
Flexible video ureterorenoscope, reusable
Model / reference
11278VSE
Primary DI / UDI-DI
04048551416976
FDA product code
FGB
GMDN term
Flexible video ureterorenoscope, reusable
Device class
Class II
Regulation number
876.1500
GUDID distribution status
In Commercial Distribution

Related devices

Category: Flexible video ureterorenoscope, reusable

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Properties

  • Sterilise before use
  • Prescription use
  • Serial number
Other properties (12, all answered No)