FDA device listing

MultiStage

FDA device listing 1776655726 · Dongguan TT Medical, Inc.

Key facts

Proprietary names MultiStage
Owner/operator Dongguan TT Medical, Inc.
Owner/operator number 10088168
Premarket submissions K222663
Product codes FGE
Device names FGE - Stents, Drains And Dilators For The Biliary Ducts
Device class Class II
Classification regulations (21 CFR) 876.5010
Review panels Gastroenterology & Urology
Registered establishments DONGGUAN TT MEDICAL, INC.
Establishment registrations 3013152301
FEI numbers 3013152301
Establishment operations Manufacturer
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • 10–99 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

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