Who is the manufacturer of DISPOSABLE PATIENT RETURN ELECTRODE?

Erbe USA, Inc. filed the 510(k) submission for DISPOSABLE PATIENT RETURN ELECTRODE (K960569).

What is the FDA product code for DISPOSABLE PATIENT RETURN ELECTRODE?

GEI. It is classified under 21 CFR 878.4400 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for DISPOSABLE PATIENT RETURN ELECTRODE?

510(k) clearance (submission type: Traditional).

What are the predicate devices for DISPOSABLE PATIENT RETURN ELECTRODE?

ConMed Disposable Return Electrodes.

Who can help prepare an FDA 510(k) submission like DISPOSABLE PATIENT RETURN ELECTRODE?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

DISPOSABLE PATIENT RETURN ELECTRODE

K960569 · Erbe USA, Inc. · GEI · Mar 11, 1996 · General, Plastic Surgery

Device Facts

Record ID	K960569
Device Name	DISPOSABLE PATIENT RETURN ELECTRODE
Applicant	Erbe USA, Inc.
Product Code	GEI · General, Plastic Surgery
Decision Date	Mar 11, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4400
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The ERBE Disposable Patient Return Electrodes are a key accessory in the efficacious application of HF surgical instruments and are intended to be used primarily with Erbe's range of Electrosurgical Generators but they are also compatible with generators from other manufacturers.

Device Story

Disposable patient return electrode; functions as grounding pad for high-frequency (HF) electrosurgical current; completes electrical circuit between patient and electrosurgical generator; prevents thermal injury at return site; used in surgical settings; operated by surgeons or surgical staff; compatible with Erbe and third-party electrosurgical generators; available with or without pre-attached cable; utilizes established materials and technology consistent with existing market devices.

Clinical Evidence

No clinical data provided. Safety and effectiveness based on established technology and materials used in existing market devices.

Technological Characteristics

Disposable conductive electrode pad; adhesive interface for patient skin contact; optional pre-attached cable; compatible with standard HF electrosurgical generators; passive electrical component.

Indications for Use

Indicated for use as a patient return electrode during high-frequency (HF) electrosurgery to cut and/or coagulate biological tissue. Suitable for patients undergoing electrosurgical procedures where HF current return is required.

Regulatory Classification

Identification

An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

Predicate Devices

ConMed Disposable Return Electrodes

Related Devices

K984276 — DISPOSABLE ELECTROSURGERY GROUNDING PAD · E & M Engineering, Inc. · Feb 10, 1999
K972269 — DISPOSABLE PATIENT RETURN ELECTRODE · Erbe USA, Inc. · Jul 9, 1997
K132136 — SINGLE USE GROUNDING PAD · Lccs Products Limited · Sep 6, 2013
K140658 — THERMOGARD DISPERSIVE ELECTRODES, THERMOGARD PLUS ABC DISPERSIVE ELECTRODES · Conmed Corporation · Jul 10, 2014
K082204 — SERIES SY DISPOSABLE ELECTROSURGICAL PAD · Ventlab Corp. · Aug 13, 2008

Submission Summary (Full Text)

{0} K960569 510(k) Notification ERBE Disposable Patient Return Electrode February 2, 1996 MAR 11 1996 # Summary of Safety and Effectiveness This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990. For more than 50 years, high-frequency (HF) surgery has been used to cut and/or coagulate biological tissue using the intrinsic thermal effect of electric current. ERBE has been working intensively during this entire period in the production and distribution of state-of-the-art HF surgical instruments and accessories. The ERBE Disposable Patient Return Electrodes are a key accessory in the efficacious application of HF surgical instruments and are intended to be used primarily with Erbe's range of Electrosurgical Generators but they are also compatible with generators from other manufacturers. The Erbe electrodes and are to be sold with and without a pre-attached cable. Erbe will offer the Return Electrodes without the pre-attached cable as these provide the user the option of purchasing a less expensive item and utilizing a re-usable cable. Disposable return electrodes have been manufactured and distributed worldwide by ConMed and the ERBE Disposable Return Electrodes utilize the same materials and technology. There are no known adverse reactions or field problems with electrodes utilizing this technology or materials It is Erbe's intention to apply for ISO Registration and market this product under the CE mark. It is Erbe policy that all product marketed under the Erbe name are so registered. Based upon the documents enclosed in this Notification, we believe the ERBE Disposable Patient Return Electrodes are Safe and Effective for their intended purpose when used in accordance with the Instructions for Use.