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R2 Electrosurgical Return Electrode #225ETC

by R2 Corp. 510(k)

Active United States

510(k) K800933

Overview

This device is an Electrode, Gel, Electrosurgical (per FDA classification JOT, Regulation 878.4400), designed as a return electrode for electrosurgical procedures. It facilitates the completion of electrical circuits in electrosurgery by conducting current away from the surgical site, aiding in tissue cutting and coagulation while minimizing thermal damage.

The R2 Electrosurgical Return Electrode #225ETC is intended for single-use in controlled surgical environments, adhering to FDA’s Substantially Equivalent (SESE) determination under a Traditional 510(k) clearance (K800933). Supplied sterile, it is classified as a Class II device and must be used in accordance with electrosurgical safety protocols. Storage and handling follow standard sterile medical device procedures.

AI-generated from registry data, 19 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK800933 Date20 May 1980ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 6 Oct 2026.

Specification

510(k)

Full name
R2 Electrosurg. Return Elect. #225ETC.
510(k) Number
FDA Product Code
JOT
Device Class
Class II
Regulation
21 CFR Part 878.4400
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the primary purpose of the R2 Electrosurgical Return Electrode #225ETC. in surgical procedures?

    The R2 Electrosurgical Return Electrode #225ETC. is designed as a return electrode to complete the electrical circuit during electrosurgery. It conducts current away from the surgical site, enabling safe tissue cutting and coagulation while helping to reduce thermal damage to surrounding tissues.

  • Is the R2 Electrosurgical Return Electrode #225ETC. intended for reuse, or is it meant for single-use only?

    The device is explicitly intended for single-use only in controlled surgical environments. This aligns with standard sterile medical device practices to ensure patient safety and prevent cross-contamination.

  • How should the R2 Electrosurgical Return Electrode #225ETC. be stored, and is it supplied sterile?

    Yes, the device is supplied sterile and must be stored following standard sterile medical device procedures. Proper storage ensures its integrity and readiness for use in surgical settings.

  • What regulatory pathway was followed for the FDA clearance of this device, and what classification does it hold?

    The R2 Electrosurgical Return Electrode #225ETC. received a Traditional 510(k) clearance (K800933) under the FDA’s Substantially Equivalent (SESE) determination. It is classified as a Class II device and adheres to electrosurgical safety protocols as required by regulation 878.4400.