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Return Electrode Clamp Shell Cord Model RC 201

by New Deantronics, Ltd. 510(k)

Active United States

510(k) K982130

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK982130 Date7 Aug 1998ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

1 recall · FDA

    • Terminated Z-1142-2010 FDA Unclassified (pre-2012) initiated 22 Jan 2010

    Mislabeling: Boxes labeled with the order code 3508M may contain a cable for the order code 3405M, and boxes labeled with order code 3405M may contain a cable for order code 3508M.

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, 22 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 Return Electrode Clamp Shell Cord Model RC 201 is a patient return electrode conductor cable designed as an electrosurgery accessory. It functions by connecting patient return electrodes that lack integral cords to electrosurgical units.

This device is compatible with electrosurgical units that utilize Valleylab E7509 return electrode monitoring systems. It is an FDA 510(k) cleared device classified under regulation number 878.4400 as a Class II electrosurgical cutting and coagulation accessory.

Other devices from New Deantronics, Ltd.

Questions

AI-generated answers, 22 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 primary function of the RC 201 cord?

    The Return Electrode Clamp Shell Cord Model RC 201 is designed to connect patient return electrodes that do not have integral cords to electrosurgical units, facilitating the safe return path for electrosurgical current.

  • Which electrosurgical units are compatible with this cord?

    This device is specifically designed for compatibility with electrosurgical units that utilize the Valleylab E7509 return electrode monitoring system.

  • What is the regulatory status of the Model RC 201?

    The Model RC 201 is an FDA 510(k) cleared device. It is classified under regulation number 878.4400 as a Class II electrosurgical cutting and coagulation accessory.