Skip to content

WEREWOLF COBLATION System, COBLATION HALO Wand

by ArthroCare Corporation

510(k) K192027

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK192027 Date20 Dec 2019ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
GEI
Device Class
Class II
Regulation
21 CFR Part 878.4400
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Werewolf Coblation System is a bipolar RF generator with an integrated fluid module, foot control, and a sterile single-use Coblation Halo Wand. It delivers RF energy to wand electrodes to create a plasma field for tissue ablation, resection, and coagulation. The system has three distinct Coblation Technology modes: Low, Med, and High.

The Werewolf Coblation System is supplied with a sterile single-use Coblation Halo Wand and is used in ENT procedures. The system is controlled from either the wand, foot pedal, or touch screen interface. It has received FDA 510(k) authorization, with the reference number K192027.

Other devices from ArthroCare Corporation

See all devices from ArthroCare Corporation →

Questions

AI-generated answers, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Werewolf Coblation System used for?

    The Werewolf Coblation System is used in ENT procedures for tissue ablation, resection, and coagulation, utilizing Coblation Technology in three distinct modes: Low, Med, and High.

  • Is the Coblation Halo Wand reusable?

    No, the Coblation Halo Wand is supplied as a sterile single-use device, ensuring safety and preventing cross-contamination.

  • How is the Werewolf Coblation System controlled?

    The system can be controlled from either the wand, foot pedal, or touch screen interface, providing flexibility and ease of use during procedures.

  • What is the regulatory status of the Werewolf Coblation System?

    The Werewolf Coblation System has received FDA 510(k) authorization, with the reference number K192027, indicating it is substantially equivalent to a predicate device.