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Vacurect Vacuum Constriction Device

by Vacurect Manufacturing (Pty), Ltd. 2 variants

510(k) K020969

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 NumberK020969 Date5 Jun 2002ClearedStatusActive

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  • Withdrawn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
LKY
FDA applicant
Vacurect Manufacturing (Pty) , Ltd.
Device Class
Class II
Regulation
21 CFR Part 876.5020
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 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 Vacurect Vacuum Constriction Device is an external penile rigidity device designed to create and maintain an erection. It falls under the classification of devices used for treating erectile dysfunction by applying mechanical vacuum constriction to the penis, as defined by its regulatory classification.

This device is supplied as a reusable system comprising a vacuum tube, pump sleeve, spacer ring, O-rings, and a flexible rubber constriction ring. It is intended for use in clinical settings such as urology and is regulated under FDA 510(k) clearance (K020969) with a classification of Class II. The device operates by generating a vacuum within the tube, which is then sealed with the constriction ring to maintain rigidity. No specific sterility or MRI safety information is provided in the available data.

Other devices from Vacurect Manufacturing (Pty), Ltd.

Questions

AI-generated answers, 19 Sep 2026

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

  • Is the Vacurect Vacuum Constriction Device intended for single-use or reusable in clinical settings?

    The Vacurect Vacuum Constriction Device is designed as a reusable system. It includes components like a vacuum tube, pump sleeve, spacer ring, O-rings, and a flexible rubber constriction ring, all meant to be used repeatedly in clinical settings such as urology. Since it is not described as disposable or sterile, proper cleaning and maintenance between uses are implied.

  • What components does the Vacurect Vacuum Constriction Device include, and how does it work?

    The device consists of a vacuum tube, pump sleeve, spacer ring, O-rings, and a flexible rubber constriction ring. It works by placing the penis inside the vacuum tube, activating the pump sleeve to create suction, and then sealing the base of the tube with the constriction ring to maintain rigidity. This mechanical vacuum constriction helps achieve and sustain an erection for clinical use.

  • Are there different sizes or models available for the Vacurect Vacuum Constriction Device?

    The provided data lists multiple registration numbers (e.g., 3016028125, 3015200846), which may correspond to different sizes or variations of the device. While exact sizing details are not specified, these identifiers suggest the manufacturer offers multiple configurations to accommodate varying patient anatomies. For precise sizing, refer to the manufacturer’s product catalog or consult their technical support.

  • How is the Vacurect Vacuum Constriction Device regulated, and what does that mean for clinical use?

    The device is regulated under the FDA 510(k) clearance process (K020969) and classified as Class II. This means it has been determined to be substantially equivalent to a legally marketed predicate device and meets FDA requirements for safety and effectiveness. Clinically, this implies it has undergone review by the FDA’s Gastroenterology and Urology advisory committees and is approved for use in treating erectile dysfunction via external penile rigidity.

  • Is there any information about sterility or MRI safety for the Vacurect Vacuum Constriction Device?

    The available data does not specify sterility requirements or MRI safety for the Vacurect Vacuum Constriction Device. Since it is intended for reusable clinical use, proper cleaning and disinfection protocols should be followed. For MRI safety, users should consult the manufacturer’s instructions or contact Vacurect Manufacturing directly, as no explicit guidance is provided in the regulatory documentation.