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Electrode, Model E7504 Prep II

by Valleylab, Inc.

510(k) K790296

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 NumberK790296 Date12 Apr 1979ClearedStatusActive

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  • Withdrawn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
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, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Electrode, Model E7504 Prep II is a patient return electrode designed for use in electrosurgical procedures. It facilitates the safe conduction of electrical current during surgery, ensuring proper grounding of the patient to prevent complications. Constructed from stainless steel, this device is intended for monopolar electrosurgical systems to assist in cutting and coagulation of tissues. Its design supports stable contact and effective current return during open surgical interventions.

This electrode is supplied as a single-use device, intended for use in general and plastic surgery settings. It requires no sterilization and is provided ready for immediate application. The device is classified under product code GEI and has been cleared by the FDA via a 510(k) Premarket Notification (K790296) under the Traditional review pathway. No additional regulatory markings or MRI safety considerations are specified in the available data.

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Questions

AI-generated answers, 1 Oct 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 E7504 Prep II Electrode designed for?

    The E7504 Prep II Electrode is specifically designed for use in monopolar electrosurgical procedures. It facilitates the safe conduction of electrical current during surgery by providing proper patient grounding, which helps prevent complications like burns or erratic current flow. This design ensures stable contact and effective current return, making it ideal for cutting and coagulation tasks in open surgical interventions.

  • Is the E7504 Prep II Electrode reusable or single-use?

    The E7504 Prep II Electrode is intended for single-use only. It is supplied ready for immediate application, eliminating the need for sterilization or reprocessing. This design ensures hygiene and safety, as each electrode is used once and then discarded.

  • What surgical settings is the E7504 Prep II Electrode approved for?

    This electrode is approved for use in general and plastic surgery settings. Its design supports stable electrical conduction during open surgical procedures, making it suitable for these specific applications where monopolar electrosurgery is commonly employed.

  • Does the E7504 Prep II Electrode require sterilization?

    No, the E7504 Prep II Electrode does not require sterilization. It is supplied as a single-use device, pre-sterilized and ready for immediate use. This simplifies surgical workflows by reducing preparation time and ensuring consistent sterility for each procedure.

  • What material is the E7504 Prep II Electrode made from?

    The E7504 Prep II Electrode is constructed from stainless steel. This material provides durability, conductivity, and corrosion resistance, ensuring reliable performance during electrosurgical procedures while maintaining patient safety.