FDA device listing

Hollister

FDA device listing 1778104110 · Hollister Inc.

Key facts

Proprietary names Hollister
Owner/operator Hollister Inc.
Owner/operator number 1480288
Premarket submissions K893888
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 HOLLISTER, INC., HOLLISTER INCORPORATED
Establishment registrations 1480288, 2320961
FEI numbers 1480288, 3003172243
Establishment operations Repackager/Relabeler, Specification Developer
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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