Morce Power Plus and Variocarve Morcellator
FDA 510(k)Class II (US FDA 510(k))
by Nouvag AG
Identifiers
- 510(k) Number
- K080365 FDA 510(k)
- FDA Product Code
- HET FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 884.1720 FDA 510(k)
- Regulation Number
- 884.1720 FDA 510(k)
- Advisory Committee
- Obstetrics/Gynecology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Morce Power Plus and Variocarve Morcellator is a laparoscope, gynecologic (and accessories) device intended for use in operative laparoscopy. It consists of a rotating cylindrical tube with a cutting blade at the distal end and is designed to mechanically morcellate and extract tissue such as myomata or the uterus during laparoscopic general surgical and gynecologic procedures.
The device is supplied as a drive control unit for a mechanical morcellator and is operated by a surgeon during operative laparoscopy. It received FDA 510(k) clearance (K080365) on June 29, 2009, and is classified as a Class II device under regulation number 884.1720. The device is manufactured by Nouvag AG at Reusswehrstrasse 1, Gebenstorf, CH-5412, Switzerland.
Frequently asked questions
What is the Morce Power Plus Morcellator used for?
The Morce Power Plus Morcellator is used for mechanically morcellating and extracting tissue such as myomata or the uterus during laparoscopic general surgical and gynecologic procedures.
How is the Morce Power Plus Morcellator supplied?
The device is supplied as a drive control unit for a mechanical morcellator.
Is the Morce Power Plus Morcellator a single-use or reusable device?
The device data does not specify whether the Morce Power Plus Morcellator is single-use or reusable.
What is the regulatory classification of the Morce Power Plus Morcellator?
The Morce Power Plus Morcellator is classified as a Class II device under regulation number 884.1720.
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: Morce Power Plus and Variocarve Morcellator, 510(k) Premarket Notification, fda.innolitics.com, Richard Wolf Morce Power Plus AI Chat & PDF Access | Manualzz
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K080365 | Class II | Active |
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Manufacturer
- Manufacturer
- Nouvag AG
Sources (1)
- FDA 510(k) K080365 24 fields · synced Sep 27, 2026