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ArthroCare System 15000 Controller, ArthroWands

by Arthrocare Corp.

510(k) K093165

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 · Special NumberK093165 Date4 Dec 2009ClearedStatusActive

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  • Withdrawn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, 26 Sep 2026

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

The ArthroCare System 15000 Controller is a bipolar, high-frequency electrosurgical system used in arthroscopic and orthopedic surgery. It comprises a Controller (generator), disposable bipolar Wands, and a Foot Control. The system delivers high-frequency energy to the surgical site to perform soft tissue resection, ablation, coagulation, and hemostasis.

The system is supplied as a controller with disposable bipolar Wands and a Foot Control. It is intended for use in general and plastic surgery. The device received FDA 510(k) clearance with K093165 on December 4, 2009, and is classified under product code GEI.

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Questions

AI-generated answers, 26 Sep 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 ArthroCare System 15000 Controller used for?

    The ArthroCare System 15000 Controller is a bipolar, high-frequency electrosurgical system used in arthroscopic and orthopedic surgery to perform soft tissue resection, ablation, coagulation, and hemostasis.

  • What components are included with the ArthroCare System 15000 Controller?

    The system is supplied as a controller with disposable bipolar Wands and a Foot Control. These components work together to deliver high-frequency energy to the surgical site during procedures.

  • Is the ArthroCare System 15000 Controller reusable or single-use?

    The controller and Foot Control are reusable components, while the bipolar Wands are disposable. This design ensures optimal performance and safety during surgical procedures.

  • What regulatory approvals does the ArthroCare System 15000 Controller have?

    The device received FDA 510(k) clearance with K093165 on December 4, 2009, and is classified under product code GEI. It is intended for use in general and plastic surgery.