Skip to content

Flex-X 11278AU1

by Karl Storz SE & CO. KG

Flex-X 11278AU1 is a Class II device made by Karl Storz SE & CO. KG, listed in FDA GUDID since 23 Sep 2016 (UDI-DI 04048551226438), 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 Number04048551226438 UDI-DI Date23 Sep 2016ListedStatusListed 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  • Withdrawn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 fibreoptic ureterorenoscope
Model / reference
11278AU1
Primary DI / UDI-DI
04048551226438
FDA product code
FGB
GMDN term
Flexible fibreoptic ureterorenoscope
Device class
Class II
Regulation number
876.1500
GUDID distribution status
In Commercial Distribution

Related devices

Category: Flexible fibreoptic ureterorenoscope

Other devices from Karl Storz SE & CO. KG

See all devices from Karl Storz SE & CO. KG →

Properties

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