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Mega 2000

by Megadyne Medical Products, Inc.

510(k) K982826

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

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 NumberK982826 Date6 Nov 1998ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1994-2023 FDA Class I initiated 1 Jun 2023

    Firm has received reports of patient burns in surgical procedures where device was used.

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  • Withdrawn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, 20 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 Mega 2000 is a reusable patient return electrode, classified under product code GEI (General, Plastic Surgery). It is designed to facilitate electrical current return during surgical procedures, ensuring safe and effective operation of electrocautery and other electrosurgical devices. Constructed from durable plastic, it is intended for repeated use in clinical settings where reliable performance is critical.

Supplied as a reusable device, the Mega 2000 is intended for use in operating rooms and surgical environments. It has received FDA clearance under a 510(k) submission (K982826) and was determined to be substantially equivalent to a predicate device. The device is not described as sterile or single-use, and no MRI safety information is provided in the available data. Storage and handling instructions are not specified in the regulatory records.

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Questions

AI-generated answers, 20 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 Mega 2000 used for in surgical settings and how does it function?

    The Mega 2000 is a reusable patient return electrode designed to provide a safe and effective pathway for electrical current return during surgical procedures. It works in conjunction with electrocautery and other electrosurgical devices to ensure proper grounding, which is essential for safe operation and preventing electrical hazards. Its durable plastic construction allows for repeated use in operating rooms and surgical environments where reliability is key.

  • Is the Mega 2000 intended for single-use or can it be reused in clinical settings?

    The Mega 2000 is explicitly described as a reusable device, not intended for single-use. Its design and classification under product code GEI (General, Plastic Surgery) emphasize durability and repeated use in clinical environments where consistent performance is required. No sterility claims are made, so proper cleaning and maintenance protocols must be followed for reuse.

  • What are the key details about the regulatory approval process for the Mega 2000?

    The Mega 2000 received FDA clearance through a 510(k) submission (K982826) filed in 1998, with a decision date of November 6, 1998. It was determined to be substantially equivalent to a predicate device under the General, Plastic Surgery category (product code GEI). The clearance was granted via a traditional review process, and no additional regulatory status beyond this is specified in the available data.

  • Are there any specific storage or handling instructions provided for the Mega 2000?

    The regulatory records for the Mega 2000 do not include explicit storage or handling instructions. Since it is a reusable device, proper cleaning and maintenance procedures must be established by the facility to ensure safety, functionality, and longevity. Users should follow general best practices for reusable medical devices until specific guidelines are provided by the manufacturer.