FDA device listing

Magill Catheter Intro. Forceps

FDA device listing 1522504912 · Sklar Corporation

Key facts

Proprietary names Magill Catheter Intro. Forceps
Owner/operator Sklar Corporation
Owner/operator number 10023634
Premarket submissions K801273
Product codes KOA
Device names KOA - Surgical Instruments, G-U, Manual (And Accessories)
Device class Class I
Classification regulations (21 CFR) 876.4730
Review panels Gastroenterology & Urology
Registered establishments Sklar Corporation, Sklar Corporation - Warehouse
Establishment registrations 2431166, 3015895045
FEI numbers 2523865, 3015895045
Establishment operations 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

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