FDA device listing

Endo Clip III

FDA device listing 1171475528 · Medtronic, Inc.

Key facts

Proprietary names Endo Clip III
Owner/operator Medtronic, Inc.
Owner/operator number 2112641
Premarket submissions K100242
Product codes FZP, GDO
Device names FZP - Clip, Implantable, GDO - Applier, Surgical, Clip
Device class Class I, Class II
Classification regulations (21 CFR) 878.4300, 878.4800
Review panels General & Plastic Surgery
Registered establishments Medtronic Distribution Center, Medtronic Engineering and Innovation Center (MEIC)
Establishment registrations 3009380063, 3018094310
FEI numbers 3009380063, 3018094310
Establishment operations Complaint File Establishment, Manufacturer
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • None 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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