FDA device listing

Bantam PRO Electrosurgical Generator,DERM 941 High Frequency Desiccator,DERM 942 High Frequency Desiccator

FDA device listing 1636272399 · Apyx Medical Corporation

Key facts

Proprietary names Bantam PRO Electrosurgical Generator,DERM 941 High Frequency Desiccator,DERM 942 High Frequency Desiccator
Owner/operator Apyx Medical Corporation
Owner/operator number 9910100
Product codes GEI
Device names GEI - Electrosurgical, Cutting & Coagulation & Accessories
Device class Class II
Classification regulations (21 CFR) 878.4400
Review panels General & Plastic Surgery
Registered establishments Apyx Medical Corporation
Establishment registrations 3007593903
FEI numbers 3007593903
Establishment operations Contract Manufacturer
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