FDA device listing

Adenotome,Dissector,Ear knife,Incision knife,Knife,Lancet knife,Laryngeal knife,Roller knife,Round knife,Scalpel…

FDA device listing 1147398527 · Arvato SE

Key facts

Proprietary names Adenotome,Dissector,Ear knife,Incision knife,Knife,Lancet knife,Laryngeal knife,Roller knife,Round knife,Scalpel handle,Sickle knife,Swivel knife,Tonsil knife
Owner/operator Arvato SE
Owner/operator number 10053073
Product codes KTG
Device names KTG - Knife, Ent
Device class Class I
Classification regulations (21 CFR) 874.4420
Review panels Ear, Nose, & Throat
Registered establishments Arvato SE
Establishment registrations 3013247477
FEI numbers 3013247477
Establishment operations Repackager/Relabeler
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • None listed 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

Browse all FDA device listings