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MFG-05

FDA 510(k)

Class II (US FDA 510(k))

510(k) K230780

by Zimmer MedizinSysteme GmbH

Identifiers

510(k) Number
K230780 FDA 510(k)
FDA Product Code
KPI FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.5320 FDA 510(k)
Regulation Number
876.5320 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

MFG-05 is an electrical stimulator for incontinence, classified as a non-implantable device. It received FDA 510(k) clearance under K230780 on October 5, 2023, and is substantially equivalent to a legally marketed predicate device.

The device is manufactured by Zimmer MedizinSysteme GmbH, located at Junkersstrasse 9, Neu-Elm, 89231, Germany. It is intended for use in gastroenterology and urology settings, as indicated by the advisory committee classification and openFDA medical specialty description.

Frequently asked questions

What is the MFG-05 device used for?

The MFG-05 is an electrical stimulator intended for the treatment of incontinence, specifically designed for use in gastroenterology and urology clinical settings as indicated by its advisory committee classification and openFDA medical specialty description.

Is the MFG-05 device implantable or non-implantable?

The MFG-05 is classified as a non-implantable electrical stimulator, meaning it is designed for external use and not intended to be placed inside the body during operation.

What regulatory pathway was used for the MFG-05 device clearance?

The MFG-05 received FDA 510(k) clearance through the traditional pathway, with clearance granted under K230780 on October 5, 2023, based on substantial equivalence to a legally marketed predicate device.

Who manufactures the MFG-05 device and where is it located?

The MFG-05 is manufactured by Zimmer MedizinSysteme GmbH, located at Junkersstrasse 9, Neu-Elm, 89231, Germany, as specified in the device authorization and establishment registration details.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: MFG-05 - FDA 510 (k) K230780 | MedTracker - aiqixie.com, ZIMMER MFG-05 INSTRUCTIONS FOR USE MANUAL Pdf Download, Mfg-05 - Beudamed, PDF October 5, 2023 - Food and Drug Administration, Zimmer MedizinSysteme GmbH | With 50 years of experience, Zimmer ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Zimmer MedizinSysteme GmbH

Sources (1)

  • FDA 510(k) K230780 24 fields · synced Oct 6, 2026