FDA device listing

Heatwave Electrode

FDA device listing 1831569070 · CONMED CORPORATION

Key facts

Proprietary names Heatwave Electrode
Owner/operator CONMED CORPORATION
Owner/operator number 1317214
Premarket submissions K991830
Product codes JOS
Device names JOS - Electrode, Electrosurgical
Device class Class II
Classification regulations (21 CFR) 878.4400
Review panels General & Plastic Surgery
Registered establishments Linvatec Corporation
Establishment registrations 1017294
FEI numbers 1017294
Establishment operations Manufacturer
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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