510(k) · Cleared
ClearedGynecare Laparoscopic Morcellator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ETHICON, Inc. · HET Laparoscope, Gynecologic (And Accessories)
Cleared on Feb 7, 2000 after a 90-day review. The FDA summary names its predicate without a number. 6 later devices descend from it.
- Decided
- Feb 7, 2000
- Review
- 90 days
- Class
- Class II
- Product code
- HET
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 4 citing it directly.
- This deviceK993801 Gynecare Laparoscopic MorcellatorETHICON, Inc. · 2000
- Descendant · cites it directly · 1 of its ownK101458 Lina Xcise Model Mor-1515Lina Medical Aps · 2011
- Descendant · cites it directly · 1 of its ownK080093 PKS Plasma Morcellator, Models 962000PK, 3620PKGyrus Acmi, Inc. · 2008
- Descendant · 2 generations on · 0 of its ownK243821 i-CutA.M.I. Agency For Medical Innovations GmbH · 2025
- Descendant · 2 generations on · 0 of its ownK161038 PK MorcellatorGyrus Acmi, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK091010 Trokamed MorcellatorTrokamed GmbH · 2011 · Recalled
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K101458Lina Xcise Model Mor-1515Lina Medical Aps · 2011 · cites it directly1descendant
- K080093PKS Plasma Morcellator, Models 962000PK, 3620PKGyrus Acmi, Inc. · 2008 · cites it directly1descendant
- K243821i-CutA.M.I. Agency For Medical Innovations GmbH · 2025 · 2 generations on0descendants
- K161038PK MorcellatorGyrus Acmi, Inc. · 2016 · 2 generations on0descendants
- K091010Trokamed MorcellatorTrokamed GmbH · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K993801 | Gynecare Laparoscopic Morcellator | ETHICON, Inc. | 2000 | — |
| +1 | K101458 | Lina Xcise Model Mor-1515 | Lina Medical Aps | 2011 | — |
| +1 | K080093 | PKS Plasma Morcellator, Models 962000PK, 3620PK | Gyrus Acmi, Inc. | 2008 | — |
| +2 | K243821 | i-Cut | A.M.I. Agency For Medical Innovations GmbH | 2025 | — |
| +2 | K161038 | PK Morcellator | Gyrus Acmi, Inc. | 2016 | — |
| +1 | K091010 | Trokamed Morcellator | Trokamed GmbH | 2011 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2016 | 1 | 0 |
| 2025 | 1 | 0 |
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
What was it cleared against? (1)
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 | Decided |
|---|---|---|---|
| * | — | Gynecare Laparoscopic Morcellator Named without a submission number |
What descends from it? (6)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K101458 (Lina Medical Aps, 2011) has gone furthest, with 1 descendant of its own.
How does its category compare?
All HET devicesHET Laparoscope, Gynecologic (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HET
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HET
269in 2021
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HET
4in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HET
4,513in 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?
Indicated for cutting, coring and extracting tissue in operative laparoscopy, including laparoscopic general surgical procedures, laparoscopic urologic procedures such as nephrectomy, and laparoscopic gynecologic procedures such as myomectomy and hysterectomy.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K993801 · printed Nov 5, 2026
Cite this page
510(k) Report. “K993801: Gynecare Laparoscopic Morcellator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K993801
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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