510(k) · Cleared
Recalled · 2009Gynecare Morcellex Tissue Morcellator, Models MX0100 and MX0100R
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 Jul 14, 2006 after an 88-day review. The FDA summary names its predicate without a number. 8 later devices descend from it. It has been recalled once.
- Decided
- Jul 14, 2006
- Review
- 88 days
- Class
- Class II
- Product code
- HET
- Recalls
- 1
- Predicates
- 0
8 later devices descend from it, 1 citing it directly.
- This deviceK061050 Gynecare Morcellex Tissue Morcellator, Models MX0100 and MX0100RETHICON, Inc. · 2006
- Descendant · cites it directly · 7 of its ownK091100 Myosure Hysteroscopic Tissue Removal SystemInterlace Medical, Inc. · 2009
- Descendant · 2 generations on · 6 of its ownK100559 Myosure Hysteroscopic Tissue Removal SystemInterlace Medical, Inc. · 2010
- Descendant · 3 generations on · 1 of its ownK122498 Myosure XL Tissue Removal Device (1 Pack) Myosure XL Tissue Removal…Hologic, Inc. · 2012
- Descendant · 3 generations on · 0 of its ownK131581 Myosure Tissue Removal Device (1 Pack and 3 Pack)Hologic, Inc. · 2013
- Descendant · 4 generations on · 0 of its ownK131736 Myosure Tissue Removal Device (1 Pack), Myosure Tissue Removal…Hologic, Inc. · 2013
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K091100Myosure Hysteroscopic Tissue Removal SystemInterlace Medical, Inc. · 2009 · cites it directly7descendants
- K100559Myosure Hysteroscopic Tissue Removal SystemInterlace Medical, Inc. · 2010 · 2 generations on6descendants
- K122498Myosure XL Tissue Removal Device (1 Pack) Myosure XL Tissue Removal Device (3 Pack)Hologic, Inc. · 2012 · 3 generations on1descendant
- K131581Myosure Tissue Removal Device (1 Pack and 3 Pack)Hologic, Inc. · 2013 · 3 generations on0descendants
- K131736Myosure Tissue Removal Device (1 Pack), Myosure Tissue Removal Device (3 Pack)Hologic, Inc. · 2013 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K061050 | Gynecare Morcellex Tissue Morcellator, Models MX0100 and MX0100R | ETHICON, Inc. | 2006 | — |
| +1 | K091100 | Myosure Hysteroscopic Tissue Removal System | Interlace Medical, Inc. | 2009 | — |
| +2 | K100559 | Myosure Hysteroscopic Tissue Removal System | Interlace Medical, Inc. | 2010 | — |
| +3 | K122498 | Myosure XL Tissue Removal Device (1 Pack) Myosure XL Tissue Removal Device (3… | Hologic, Inc. | 2012 | — |
| +3 | K131581 | Myosure Tissue Removal Device (1 Pack and 3 Pack) | Hologic, Inc. | 2013 | — |
| +4 | K131736 | Myosure Tissue Removal Device (1 Pack), Myosure Tissue Removal Device (3 Pack) | Hologic, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 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 X-TRACT Tissue Morcellator Named without a submission number |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K091100 | Myosure Hysteroscopic Tissue Removal System | 2009 | 7 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 28, 2009 | Not classified | Z-0173-2010 | Device Design | There is the potential for the duckbill seal to become dislodged. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K091100 (Interlace Medical, Inc., 2009) has gone furthest, with 7 descendants 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?
The GYNECARE MORCELLEX Tissue Morcellator is indicated for cutting, coring and extracting tissue during operative laparoscopy, including laparoscopic general surgical procedures, laparoscopic urologic procedures, and laparoscopic gynecologic procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061050 · printed Nov 5, 2026
Cite this page
510(k) Report. “K061050: Gynecare Morcellex Tissue Morcellator, Models MX0100 and MX0100R.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061050
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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