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Arthrocare Monopolar Electrosurgery Loop

by Arthrocare Corp.

510(k) K970526

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 NumberK970526 Date28 May 1997ClearedStatusActive

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  • Withdrawn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
FAS
Device Class
Class II
Regulation
21 CFR Part 876.4300
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 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 Monopolar Electrosurgery Loop is an active electrosurgical electrode device intended for use in urological and gastroenterological procedures. It is designed to resect soft tissue and provide hemostasis during general urological surgery using high-frequency electrical energy.

This device is supplied as a single-use, non-sterile accessory that requires connection to an electrosurgical generator. It is not MRI safe and should be stored in accordance with manufacturer instructions. The device received FDA 510(k) clearance (K970526) on May 28, 1997, and is classified as a Class II medical device under regulation number 876.4300.

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Questions

AI-generated answers, 27 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 Monopolar Electrosurgery Loop used for?

    It is intended for use in urological and gastroenterological procedures to resect soft tissue and provide hemostasis during general urological surgery using high-frequency electrical energy.

  • Is the Arthrocare Monopolar Electrosurgery Loop sterile when supplied?

    No, it is supplied as a single-use, non-sterile accessory and must be sterilized by the user before use according to manufacturer instructions.

  • Can the Arthrocare Monopolar Electrosurgery Loop be reused?

    No, it is designed as a single-use device and should not be reused due to risks of contamination, material degradation, and compromised performance.

  • What equipment is required to operate the Arthrocare Monopolar Electrosurgery Loop?

    It requires connection to an electrosurgical generator to deliver high-frequency electrical energy for tissue resection and hemostasis during procedures.

  • How should the Arthrocare Monopolar Electrosurgery Loop be stored?

    It should be stored in accordance with the manufacturer’s instructions to maintain device integrity and ensure safe performance prior to use.