510(k) · Cleared
ClearedTruclear Morcellator System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc. · HIH Hysteroscope (And Accessories)
Cleared on Mar 30, 2011 as substantially equivalent to K031787 (Smith & Nephew, Inc., 2003) after an 83-day review. Its family tree reaches back 2 generations to 1995. 25 later devices descend from it.
- Decided
- Mar 30, 2011
- Review
- 83 days
- Class
- Class II
- Product code
- HIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K953695 (1995). 4 ancestors in all. 25 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK953695 Dyonics Disposable Arthroscopic BladesSmith & Nephew Dyonics, Inc. · 1995
- 1 generation backK031787 Smith & Nephew Iur Morcellation SystemSmith & Nephew, Inc. · 2003 · Recalled
- This deviceK110038 Truclear Morcellator SystemSmith & Nephew, Inc. · 2011
- Descendant · cites it directly · 24 of its ownK132015 Truclear Morcellation System and Truclear MorcellatorsSmith & Nephew, Inc. · 2013 · Recalled
- Descendant · 2 generations on · 14 of its ownK142029 Myosure Hysteroscopic Tissue Removal SystemHologic, Inc. · 2014
- Descendant · 3 generations on · 6 of its ownK152723 Myosure Hysteroscopic Tissue Removal System and Myosure Tissue…Hologic, Inc. · 2015
- Descendant · 4 generations on · 5 of its ownK172566 Myosure Hysteroscopic Tissue Removal System and Myosure Tissue…Hologic, Inc. · 2017
- Descendant · 2 generations on · 4 of its ownK190372 Aveta SystemMeditrina, Inc. · 2019
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 25 · See all- K132015Truclear Morcellation System and Truclear MorcellatorsSmith & Nephew, Inc. · 2013 · cites it directly24descendants
- K142029Myosure Hysteroscopic Tissue Removal SystemHologic, Inc. · 2014 · 2 generations on14descendants
- K152723Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal DevicesHologic, Inc. · 2015 · 3 generations on6descendants
- K172566Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal DevicesHologic, Inc. · 2017 · 4 generations on5descendants
- K190372Aveta SystemMeditrina, Inc. · 2019 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K953695 | Dyonics Disposable Arthroscopic Blades | Smith & Nephew Dyonics, Inc. | 1995 | — |
| −1 | K031787 | Smith & Nephew Iur Morcellation System | Smith & Nephew, Inc. | 2003 | 1 |
| 0 (this device) | K110038 | Truclear Morcellator System | Smith & Nephew, Inc. | 2011 | — |
| +1 | K132015 | Truclear Morcellation System and Truclear Morcellators | Smith & Nephew, Inc. | 2013 | 1 |
| +2 | K142029 | Myosure Hysteroscopic Tissue Removal System | Hologic, Inc. | 2014 | — |
| +3 | K152723 | Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices | Hologic, Inc. | 2015 | — |
| +4 | K172566 | Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices | Hologic, Inc. | 2017 | — |
| +2 | K190372 | Aveta System | Meditrina, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 5 | 0 |
| 2020 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2026 | 4 | 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 HIH? 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 HIH device
- #1 K232003 Endoscopic Video Image Processor, Single-Use…score 16.1 · 12 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 |
|---|---|---|---|
| * | K031787 | Smith & Nephew Iur Morcellation SystemSummary page 1…rketed device in commercial distribution: Smith & Nephew LUR Morcellation System. E. Description of Device The TRUCLEAR Morcellator System was first introduced in K03 1787. The method of operation is mechanical resection and suction to cut and remove submucous myomas and endometrial polyps from… | 2003 |
What descends from it? (25)
See all 251 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K132015 | Truclear Morcellation System and Truclear Morcellators | 2013 | 24 |
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?
- The line of descent spans 16 years and passes through 2 companies; a new generation was cleared every 8.2 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K132015 (Smith & Nephew, Inc., 2013) has gone furthest, with 24 descendants of its own.
- 3 other devices also cite its predicate K031787.
How does its category compare?
All HIH devicesHIH Hysteroscope (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 · HIH
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HIH
111in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HIH
3so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HIH
1,698in 2025
MAUDE reports naming product code HIH, 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 | 1 | — | 0 | 7 |
| 2008 | 2 | — | 0 | 12 |
| 2009 | 4 | 130 | 0 | 17 |
| 2010 | 4 | 109 | 0 | 31 |
| 2011 | 3 | 118 | 0 | 59 |
| 2012 | 4 | 25 | 0 | 78 |
| 2013 | 5 | 144 | 0 | 111 |
| 2014 | 2 | — | 0 | 125 |
| 2015 | 5 | 52 | 0 | 211 |
| 2016 | 3 | 106 | 0 | 172 |
| 2017 | 2 | — | 0 | 336 |
| 2018 | 8 | 135 | 0 | 182 |
| 2019 | 14 | 91 | 1 | 220 |
| 2020 | 7 | 88 | 0 | 253 |
| 2021 | 4 | 194 | 0 | 193 |
| 2022 | 2 | — | 0 | 289 |
| 2023 | 4 | 200 | 2 | 1,449 |
| 2024 | 6 | 148 | 0 | 1,611 |
| 2025 | 3 | 111 | 0 | 1,698 |
| 2026 | 7 | 168 | 3 | — |
What is it indicated for?
The TRUCLEARTM Morcellator System is intended for use in gynecological procedures by trained professional gynecologists to resect and remove endometrial tissue for the following indications, submucous myomas and endometrial polyps.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110038 · printed Nov 5, 2026
Cite this page
510(k) Report. “K110038: Truclear Morcellator System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K110038
Report an extraction error
Are you the manufacturer?
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