FDA device listing

Taut

FDA device listing 1222861158 · Teleflex

Key facts

Proprietary names Taut
Owner/operator Teleflex
Owner/operator number 9062981
Premarket submissions K925559
Product codes LQR
Device names LQR - Dislodger, Stone, Biliary
Device class Class II
Classification regulations (21 CFR) 876.5010
Review panels Gastroenterology & Urology
Registered establishments Teleflex LLC (NADC), Teleflex Medical de Tecate, S. de R.L de C.V., Teleflex Medical LLC
Establishment registrations 3003898360, 3010041511, 3011137372
FEI numbers 3003898360, 3005747797, 3010041511
Establishment operations Complaint File Establishment, Manufacturer, Repackager/Relabeler
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • 1–9 UDI devices (GUDID) under the same submission
  • 1–9 Device listings citing the same submission
  • Yes Premarket submission listed

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device listings

Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.

Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database

Browse all FDA device listings