FDA device listing

Tubes, Gastrointestinal (And Accessories)

FDA device listing 1228551662 · Avanos Medical, Inc.

Key facts

Owner/operator Avanos Medical, Inc.
Owner/operator number 2022573
Premarket submissions K842076
Product codes KNT
Device names KNT - Tubes, Gastrointestinal (And Accessories)
Device class Class II
Classification regulations (21 CFR) 876.5980
Review panels Gastroenterology & Urology
Registered establishments Avanos Medical, Inc., AVENT S. de R.L. de C.V.
Establishment registrations 9611594, 3011270181
FEI numbers 3002806436, 3011270181
Establishment operations Manufacturer, Specification Developer
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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