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Surgidyne Varidyne, Model 140-2I & Model 140-2ID

by Surgidyne, Inc.

510(k) K860030

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 NumberK860030 Date12 Feb 1986ClearedStatusActive

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  • Withdrawn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
BTA
Device Class
Class II
Regulation
21 CFR Part 878.4780
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 Surgidyne Varidyne, Model 140-2I & Model 140-2ID is a portable, manual or powered aspiration pump. It is designed for surgical suctioning to remove fluids and debris from wound sites during general and plastic surgery procedures. This device operates as a suction drainage system, aiding in maintaining a clear operative field and promoting postoperative recovery by evacuating excess fluids.

The device is supplied as a reusable medical instrument and is intended for use in sterile surgical environments. It is classified under FDA regulation number 878.4780 and holds a 510(k) clearance (K860030) with a decision of Substantially Equivalent. Models 140-2I and 140-2ID are both intended for surgical applications, with no specific MRI safety restrictions noted. Storage and handling should adhere to standard surgical instrument protocols to ensure sterility and functionality.

Other devices from Surgidyne, Inc.

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 Surgidyne Varidyne used for?

    The Surgidyne Varidyne is used for surgical suctioning to remove fluids and debris from wound sites during general and plastic surgery procedures, aiding in maintaining a clear operative field and promoting postoperative recovery.

  • Is the Surgidyne Varidyne reusable?

    Yes, the Surgidyne Varidyne is supplied as a reusable medical instrument, intended for use in sterile surgical environments, and should be stored and handled according to standard surgical instrument protocols to ensure sterility and functionality.

  • Are there any specific safety restrictions for the Surgidyne Varidyne?

    No specific MRI safety restrictions are noted for the Surgidyne Varidyne Models 140-2I and 140-2ID.