FDA device listing

Nasopharyngoscope

FDA device listing 1778375573 · KARL STORZ SE & CO KG

Key facts

Proprietary names Nasopharyngoscope
Owner/operator KARL STORZ SE & CO KG
Owner/operator number 8010119
Premarket submissions K072387
Product codes EOB
Device names EOB - Nasopharyngoscope (Flexible Or Rigid)
Device class Class II
Classification regulations (21 CFR) 874.4760
Review panels Ear, Nose, & Throat
Registered establishments Karl Storz Endoscopy-America, Inc., KARL STORZ ENDOSCOPY-AMERICA, INC., KARL STORZ ENDOVISION, INC., KARL STORZ SE & CO KG, KARL STORZ SE & CO. KG, KARL STORZ VIDEO ENDOSCOPY ESTONIA OUE
Establishment registrations 1221826, 2020550, 9610617, 3004644065, 3010202439, 3010707607, 3014342096
FEI numbers 1221826, 2020550, 3002808268, 3004644065, 3007475226, 3010707607, 3014342096
Establishment operations Complaint File Establishment, Contract Manufacturer, 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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