510(k) · Cleared

Cleared

Morce Power Plus and Variocarve Morcellator

K080365510(k) TraditionalCleared Jun 29, 2009504-day reviewClass II21 CFR 884.1720

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Nouvag AG · HET Laparoscope, Gynecologic (And Accessories)

Cleared on Jun 29, 2009 as substantially equivalent to K993801 (ETHICON, Inc., 2000) and 2 other predicates after a 504-day review. Its family tree reaches back 1 generation to 1997.

Decided: Jun 29, 2009
Review: 504 days
Class: Class II
Product code: HET
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K960640 (1997). 3 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK960640 S*E*M*M* Set for Moto Drive Wisap #7689 SSM (Modification)Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh · 1997
This deviceK080365 Morce Power Plus and Variocarve MorcellatorNouvag AG · 2009

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K960640	SEMM Set for Moto Drive Wisap #7689 SSM (Modification)	Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh	1997	—
0 (this device)	K080365	Morce Power Plus and Variocarve Morcellator	Nouvag AG	2009	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0
2000	1	0

FIG. 1 — Lineage of K080365, 1997–2009Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in HET? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new HET device

#1 K250939 SIRIUS Endoscope System (PR-SI-1230)score 12.9 · 11 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (3)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K993801	Gynecare Laparoscopic Morcellator Summary page 1 …cation of the predicate device or legally marketed device or devices to which substantial equivalence is beingclaimed: ETHICON, Inc. GYNECARE X-TRACT Tissue Morcellator K993801, Cleared on 02/07/2000 WISAP Gesellschaft far wissenschaftl. App.bau SEE*M SET K960640, cleared on 02/14/1997 WISAP Gesellsch…	ETHICON, Inc.	2000	—
*	K960640	SEMM Set for Moto Drive Wisap #7689 SSM (Modification) Summary page 1 …equivalence is beingclaimed: ETHICON, Inc. GYNECARE X-TRACT Tissue Morcellator K993801, Cleared on 02/07/2000 WISAP Gesellschaft far wissenschaftl. App.bau SEE*M SET K960640, cleared on 02/14/1997 WISAP Gesellschaft ffir wissenschaftl. App.bau POWER-DRIVE,WISAP Model 7688PD/7688PD1 K982515, cleared on…	Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh	1997	—
*	K982515	Power-Drive, Wisap Model #7688PD/7688PD1 Summary page 1 …Gesellschaft far wissenschaftl. App.bau SEE*M SET K960640, cleared on 02/14/1997 WISAP Gesellschaft ffir wissenschaftl. App.bau POWER-DRIVE,WISAP Model 7688PD/7688PD1 K982515, cleared on 01/19/1999 NOUVAG AG K0…	Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh	1999	—

Also cleared against K993801: 3 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

None of the 3 ancestors has a recall.
3 other devices also cite its predicate K993801.

How does its category compare?

All HET devices

HET Laparoscope, Gynecologic (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · HET

2in 2025

2007high 4 (2021) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HET

269in 2021

2007high 269 (2021) · low 176 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HET

4in 2023

2007high 4 (2008) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HET

4,513in 2025

2007high 4,513 (2025) · low 44 (2019)2025

MAUDE reports naming product code HET, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	0	—	0	181
2008	3	176	4	359
2009	1	—	1	403
2010	1	—	0	214
2011	2	—	0	417
2012	2	—	0	1,118
2013	2	—	0	1,035
2014	0	—	0	175
2015	2	—	1	124
2016	0	—	0	205
2017	2	—	0	89
2018	1	—	0	53
2019	2	—	0	44
2020	2	—	0	49
2021	4	269	0	132
2022	1	—	1	216
2023	0	—	4	824
2024	0	—	0	3,496
2025	2	—	0	4,513
2026	0	—	0	—

What is it indicated for?

The Morce Power Plus morcellator is intended for use in operative laparoscopy, including laparoscopic general surgical procedures and laparoscopic gynecological procedures to morcellate and remove tissue.

The VarioCarve morcellator is intended for morcellating and extracting tissue (e.g. removing myomata or the uterus) during laparoscopic procedures in general surgery and gynecology.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K080365 · printed Nov 6, 2026

Cite this page

510(k) Report. “K080365: Morce Power Plus and Variocarve Morcellator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080365

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026