FDA device listing

Arrow Epidural Needle

FDA device listing 2035620930 · Teleflex

Key facts

Proprietary names Arrow Epidural Needle
Owner/operator Teleflex
Owner/operator number 9062981
Premarket submissions K190026
Product codes BSP
Device names BSP - Needle, Conduction, Anesthetic (W/Wo Introducer)
Device class Class II
Classification regulations (21 CFR) 868.5150
Review panels Anesthesiology
Registered establishments Teleflex Medical LLC
Establishment registrations 3011137372
FEI numbers 3005747797
Establishment operations Complaint File Establishment
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