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Suction Coagulator

by Megadyne Medical Products, Inc.

510(k) K072559

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

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK072559 Date5 Oct 2007ClearedStatusActive

Official records

Recalls

2 recalls · 1 ongoing · FDA

    • Ongoing Z-2257-2023 FDA Class II initiated 15 Jun 2023

    An issue with the Suction Coagulator product family may lead to fluid ingress into the handpiece. Fluid ingress can lead to intermittent device activation, non-activation, or self-activation when plugged into the electrosurgery unit (ESU).

    • Terminated Z-1151-2014 FDA Class II initiated 27 Feb 2014

    Megadyne Medical Products, Inc. is voluntarily recalling Hand Control 12Fr Suction Coagulator with 10ft cord and 132405 Holster, Sterile, Disposable, Lot 132405 due to the potential for a small number of these suction coagulators to self-activate immediately on connection to the electrosurgical generator and to remain activated until it is disconnected.

Timeline

3 dated events

  1. Cleared FDA 510(k) K072559
  2. Recall initiated FDA recalls Z-1151-2014
  3. Recall initiated FDA recalls Z-2257-2023

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  • Withdrawn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

Related clearances

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 28 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 Suction Coagulator is a surgical instrument that provides simultaneous suction and electrosurgical coagulation for use in general and plastic surgery procedures. It integrates suction capability with a coagulation function to control bleeding and maintain a clear operative field.

The device was cleared by the FDA through a traditional 510(k) submission (K072559) and is classified under product code GEI for surgical devices. It is supplied by Megadyne Medical Products, Inc. in multiple sizes with hand‑switch and foot‑controlled options, allowing surgeon flexibility. The clearance indicates it is substantially equivalent to a predicate device and is intended for use in the United States.

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