Cleared Traditional

K080365 - MORCE POWER PLUS AND VARIOCARVE MORCELLATOR

K080365 is an FDA 510(k) clearance for MORCE POWER PLUS AND VARIOCARVE MORCELLATOR, manufactured by NOUVAG AG. The device is a Class 2 Obstetrics & Gynecology device with product code HET cleared through the Traditional 510(k) pathway after a 504-day FDA review.

K080365 · NOUVAG AG · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2009
Decision
504d
Days
Class 2
Risk

K080365 is an FDA 510(k) clearance for the MORCE POWER PLUS AND VARIOCARVE MORCELLATOR. Classified as Laparoscope, Gynecologic (and Accessories) (product code HET), Class II - Special Controls.

Submitted by NOUVAG AG (Gebenstorf, CH). The FDA issued a Cleared decision on June 29, 2009 after a review of 504 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1720 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Obstetrics & Gynecology submissions.

View all NOUVAG AG devices

FDA 510(k) Submission Details - K080365

510(k) Number K080365 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 2008
Decision Date June 29, 2009
Days to Decision 504 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
344d slower than avg
Panel avg: 160d · This submission: 504d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HET Device Classification - Class 2, Special Controls

Product Code HET Laparoscope, Gynecologic (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1720
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - HET Laparoscope, Gynecologic (and Accessories)

All 211
Devices cleared under the same product code (HET) and FDA review panel - the closest regulatory comparables to K080365.
ENDOEYE HD II
K111788 · Olympus America, Inc. · Jan 2012
LINA XCISE MODEL MOR-1515
K101458 · Lina Medical Aps · Mar 2011
GYNCARE MORCELLEX TISSUE MORCELLATOR
K100280 · Ethicon, Inc. · Mar 2010
ENDOSCOPIC CO2 REGULATION UNIT UCR
K081173 · Olympus Medical Systems Corporation · Dec 2008
STRYKER VIDEOSCOPE
K082451 · Stryker Endoscopy · Dec 2008
HD ENDOEYE LAPARO-THORACO VIDEOSCOPE OLYMPUS LTF TYPE VH
K080948 · Olympus Medical Systems Corporation · Sep 2008