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Electrodes (Blade, Ball, Needle, and Loop)

by Aaron Medical Industries

510(k) K942986

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 5 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 5 Oct 2026. What this means

Regulatory status

as of registry sync 5 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK942986 Date21 Mar 1995ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 5 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  • Withdrawn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
HGI
Device Class
Class II
Regulation
21 CFR Part 884.4120
Advisory Committee
Obstetrics/Gynecology
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.

These electrodes are designed for use in electrosurgical procedures, serving as conductive interfaces between electrosurgical instruments and tissue. The device includes four distinct shapes—blade, ball, needle, and loop—to accommodate various surgical applications, facilitating precise tissue manipulation, coagulation, or cutting during procedures.

Supplied as single-use devices, these electrodes are intended for sterile use in clinical settings such as obstetrics and gynecology. They are classified as Class II medical devices under FDA regulations and are authorized via 510(k) clearance (K942986). Each electrode features a standard 3/32-inch (0.24 cm) stainless steel shaft for compatibility with electrosurgical systems, ensuring reliable performance during surgical interventions.

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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 surgical procedures are these electrodes designed for?

    These electrodes are specifically designed for use in electrosurgical procedures within obstetrics and gynecology. Their four distinct shapes—blade, ball, needle, and loop—allow for precise tissue manipulation, coagulation, or cutting during surgeries such as cesarean sections, hysteroscopies, or other gynecological interventions.

  • Are these electrodes reusable or single-use?

    These electrodes are intended for single-use only. This design ensures sterility and reduces the risk of cross-contamination between patients, which is critical in clinical settings where infection control is paramount.

  • What shaft size do these electrodes use, and why is this important?

    These electrodes feature a standard 3/32-inch (0.24 cm) stainless steel shaft, ensuring compatibility with most electrosurgical systems. This standardization simplifies integration into existing surgical workflows and guarantees reliable performance during procedures.

  • How are these electrodes supplied, and what precautions should be taken?

    The electrodes are supplied as sterile, single-use devices, packaged for immediate clinical use. They should be stored in a clean, dry environment away from direct sunlight or extreme temperatures to preserve sterility and functionality until use.

  • What regulatory clearance do these electrodes hold?

    These electrodes hold FDA 510(k) clearance under the classification of Class II medical devices, with a clearance number of K942986. This clearance confirms they meet regulatory standards for safety and effectiveness in their intended use.