Arthrocare Dermatologic Electrosurgery System

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

510(k) Number

K964849 ↗

FDA Product Code

GEI

Device Class

Class II

Regulation

21 CFR Part 878.4400

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• ARTHRO Class IIb ARTC-TF-037 Intellio Shift Non-Network Enabled Controller and Foot Pedal

  Class IIb

  CE/MDR

• Arthro Class IIb ARTC-TF-038 FLOW FLEXTEND COBLATION Wand

  Class IIb

  CE/MDR GUDID on market

• FLOW FLEXTEND Wand (72290039)

  Class II

  FDA 510(k) K254122 Active Cleared 30 Mar 2026

• Arthrocare Arthroscopic Eletrosurgery System (Model 980)

  Class II

  FDA 510(k) K963123 Active Cleared 8 Oct 1996

• EVac 70 Xtra Plasma Wand with Integrated Cable, PROcise XP Plasma Wand with Integrated Cable

  Class II

  FDA 510(k) K142999 Active Cleared 19 Nov 2014

• Modification to Arthrocare Controller, Arthrocare Cable, Footswitch, Powercord, Arthrowands and Spine Wands

  Class II

  FDA 510(k) K000511 Active Cleared 13 Mar 2000

See all devices from ArthroCare Corporation →

• What is the Arthrocare Dermatologic Electrosurgery System used for?

  The Arthrocare Dermatologic Electrosurgery System is an electrosurgical device designed for cutting and coagulation during dermatologic surgical procedures. It is specifically intended to remove soft tissue and control bleeding in these medical applications.

• Is the Arthrocare Dermatologic Electrosurgery System single-use or reusable?

  The device data does not specify whether the Arthrocare Dermatologic Electrosurgery System is designed for single-use or multiple reuse. This information would typically be found in the device's instructions for use, which are not provided in the available data.

• What regulatory approvals does the Arthrocare Dermatologic Electrosurgery System have?

  The Arthrocare Dermatologic Electrosurgery System received FDA 510(k) clearance in 1997. It is classified as a Class II device with special controls under product code GEI. The clearance was determined through the traditional review process by the General and Plastic Surgery advisory committee.

• How is the Arthrocare Dermatologic Electrosurgery System supplied?

  The Arthrocare Dermatologic Electrosurgery System is supplied by Arthrocare Corp. The device is manufactured at their facility located at 595 N. Pastoria Ave., Sunnyvale, CA 94085. The specific components or packaging configurations are not detailed in the provided information.