510(k) Report

510(k) · Cleared

Recalled · Class II · 2014

Trokamed Morcellator

K091010510(k) TraditionalCleared Mar 1, 2011691-day reviewClass II21 CFR 884.1720Recalls 1

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

Trokamed GmbH · HET Laparoscope, Gynecologic (And Accessories)

Cleared on Mar 1, 2011 as substantially equivalent to K993801 (ETHICON, Inc., 2000) and 3 other predicates after a 691-day review. Its family tree reaches back 5 generations to 1987. It has been recalled once.

Decided
Mar 1, 2011
Review
691 days
Class
Class II
Product code
HET
Recalls
1
Predicates
4

Its longest line of descent runs back 5 generations to K871250 (1987). 14 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2006: 1 other ancestor2000: 1 other ancestor1997: 3 other ancestors2001: 1 other ancestor1994: 1 other ancestor1998: 1 other ancestor1995: 1 other ancestorK871250 · Intra-Articulated Arthro Power System · Richard Wolf Medical Instruments Corp. · 1987K970088 · Riwo Drive with Footswitch/Motor Handle, Coomplete,6000RPM/3000RPM/Rotary Blades and Abraders See Section 1: · Richard Wolf Medical Instruments Corp. · 1997K984521 · Riwo Drive System 2302 with Generator, Small Motor Handles, 8563.111, 8563.351 · Richard Wolf Medical Instruments Corp. · 1999K030082 · Power Control 2303 with Power Stick M4, Model# 2303.011/.901/.911, 8564.121/.851 · Richard Wolf Medical Instruments Corp. · 2003K041610 · Morce Scope Set 8970 with Power Control 2303 and Suction Pump 2207 · Richard Wolf Medical Instruments Corp. · 2004198519901995200020052010
Other ancestors, by generation 1 generation back: 3 other ancestors2 generations back: 1 other ancestor3 generations back: 2 other ancestors4 generations back: 3 other ancestors K041610 · Morce Scope Set 8970 with Power Control 2303 and Suction Pump 2207 · Richard Wolf Medical Instruments Corp. · 2004K030082 · Power Control 2303 with Power Stick M4, Model# 2303.011/.901/.911, 8564.121/.851 · Richard Wolf Medical Instruments Corp. · 2003K984521 · Riwo Drive System 2302 with Generator, Small Motor Handles, 8563.111, 8563.351 · Richard Wolf Medical Instruments Corp. · 1999K970088 · Riwo Drive with Footswitch/Motor Handle, Coomplete,6000RPM/3000RPM/Rotary Blades and Abraders See Section 1: · Richard Wolf Medical Instruments Corp. · 1997K871250 · Intra-Articulated Arthro Power System · Richard Wolf Medical Instruments Corp. · 1987−50
  1. Root · 5 generations backK871250 Intra-Articulated Arthro Power SystemRichard Wolf Medical Instruments Corp. · 1987
  2. 4 generations backK970088 Riwo Drive with Footswitch/Motor Handle…Richard Wolf Medical Instruments Corp. · 1997
  3. 3 generations backK984521 Riwo Drive System 2302 with Generator, Small Motor Handles…Richard Wolf Medical Instruments Corp. · 1999
  4. 2 generations backK030082 Power Control 2303 with Power Stick M4, Model# 2303.011/.901/.911…Richard Wolf Medical Instruments Corp. · 2003
  5. 1 generation backK041610 Morce Scope Set 8970 with Power Control 2303 and Suction Pump 2207Richard Wolf Medical Instruments Corp. · 2004
  6. This deviceK091010 Trokamed MorcellatorTrokamed GmbH · 2011
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K871250Intra-Articulated Arthro Power SystemRichard Wolf Medical Instruments Corp.1987—
−4K970088Riwo Drive with Footswitch/Motor Handle, Coomplete,6000RPM/3000RPM/Rotary…Richard Wolf Medical Instruments Corp.1997—
−3K984521Riwo Drive System 2302 with Generator, Small Motor Handles, 8563.111, 8563.351Richard Wolf Medical Instruments Corp.1999—
−2K030082Power Control 2303 with Power Stick M4, Model# 2303.011/.901/.911, 8564.121/.851Richard Wolf Medical Instruments Corp.2003—
−1K041610Morce Scope Set 8970 with Power Control 2303 and Suction Pump 2207Richard Wolf Medical Instruments Corp.2004—
0 (this device)K091010Trokamed MorcellatorTrokamed GmbH2011—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410
199510
199730
199810
200010
200110
200610
FIG. 1 — Lineage of K091010, 1987–2011Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K250939 SIRIUS Endoscope System (PR-SI-1230)score 12.9 · 11 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (4)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K993801Gynecare Laparoscopic Morcellator
Summary page 1
…H-ET, GCJ (Class 11) Common Names: Morcellator Classification Names: Endloscopic Cutting Accessory Predicate * K993801, Gynecare Laparoscopic Morcellator Device: * K061 180, Storz KSEA Rotocut Gi * K041 610, Morce Scope Set…
ETHICON, Inc.2000—
*K061180Ksea Rotocut G1 Electromechanical Morcellator
Summary page 1
…Morcellator Classification Names: Endloscopic Cutting Accessory Predicate * K993801, Gynecare Laparoscopic Morcellator Device: * K061 180, Storz KSEA Rotocut Gi * K041 610, Morce Scope Set - Morcellator o K960640, S*E*M*M* Set for Moto…
KARL STORZ Endoscopy-America, Inc.2006—
*K041610Morce Scope Set 8970 with Power Control 2303 and Suction Pump 2207
Summary page 1
…on Names: Endloscopic Cutting Accessory Predicate * K993801, Gynecare Laparoscopic Morcellator Device: * K061 180, Storz KSEA Rotocut Gi * K041 610, Morce Scope Set - Morcellator o K960640, S*E*M*M* Set for Moto Drive WISAP Device The TROKAMED MORCELL…
Richard Wolf Medical Instruments Corp.2004—
*K960640S*E*M*M* Set for Moto Drive Wisap #7689 SSM (Modification)
Summary page 1
…K993801, Gynecare Laparoscopic Morcellator Device: * K061 180, Storz KSEA Rotocut Gi * K041 610, Morce Scope Set - Morcellator o K960640, S*E*M*M* Set for Moto Drive WISAP Device The TROKAMED MORCELLATOR iscomprised of a control unit, Description: a gri…
Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh1997—

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)

Recalls of this device

DateClassRecallRoot causeReason
Jul 16, 2014Class IIZ-2145-2014Labeling Change ControlSome pages of the Instructions for Use were omitted, including pages regarding the Indications for Use, Warning, and Contraindications.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 24 years and passes through 2 companies; a new generation was cleared every 4.6 years on median.
  • None of the 14 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. 2011, this device’s year, is highlighted.

FDA decisions per year · HET

2in 2025

2008: 32009: 12010: 12011: 22012: 22013: 22015: 22017: 22018: 12019: 22020: 22021: 42022: 12025: 2
2007high 4 (2021) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HET

269in 2021

2008: 176 days median2021: 269 days median
2007high 269 (2021) · low 176 (2008)2026

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

Recalls per year · HET

4in 2023

2008: 42009: 12015: 12022: 12023: 4
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

2007: 1812008: 3592009: 4032010: 2142011: 4172012: 1,1182013: 1,0352014: 1752015: 1242016: 2052017: 892018: 532019: 442020: 492021: 1322022: 2162023: 8242024: 3,4962025: 4,513
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—0181
200831764359
20091—1403
20101—0214
20112—0417
20122—01,118
20132—01,035
20140—0175
20152—1124
20160—0205
20172—089
20181—053
20192—044
20202—049
202142690132
20221—1216
20230—4824
20240—03,496
20252—04,513
20260—0—

What is it indicated for?

The TROKAMED MORCELLATOR is a motorized unit for morcellating and extracting tissue during laparoscopic procedures, in general surgery, gynecology including the removal of myomas and hysterectomy, and urology including nephrectomy.

Indications for use as stated in the FDA summary.

Also cleared against K993801

3 other devices cite the same predicate.

  • K101458Lina Xcise Model Mor-1515Lina Medical Aps · 2011
  • K080365Morce Power Plus and Variocarve MorcellatorNouvag AG · 2009
  • K080093PKS Plasma Morcellator, Models 962000PK, 3620PKGyrus Acmi, Inc. · 2008

More from Trokamed GmbH

4 FDA decisions under this applicant name. See the company

  • K200770Mini PCNL-SystemTrokamed GmbH · 20214 Class I recalls
  • K060233Trokamed GMBH Endoscopes and AccessoriesTrokamed GmbH · 2006
  • K060232Trokamed GMBH Electrosurgical Instruments & AccessoriesTrokamed GmbH · 200610 recalls

Recent decisions in HET

The HET category page

  • K250939SIRIUS Endoscope System (PR-SI-1230)Precision Robotics (Hong Kong) Limited · 2025
  • K243821i-CutA.M.I. Agency For Medical Innovations GmbH · 2025
  • K221642SIRIUS Endoscope SystemPrecision Robotics (Hong Kong) Limited · 2022
  • K210116Video Endoscopy System, 3D Video Endoscopy SystemSurgnova Healthcare Technologies (Zhejiang) Co., Ltd. · 2021
  • K201832Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5Olympus Medical Systems Corp. · 20211 recall

https://510kreport.com/device/K091010 · printed Nov 4, 2026

Cite this page

510(k) Report. “K091010: Trokamed Morcellator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091010

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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