510(k) · Cleared
Recalled · Class II · 2022Truclear Morcellation System and Truclear Morcellators
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 Dec 13, 2013 as substantially equivalent to K110038 (Smith & Nephew, Inc., 2011) and 3 other predicates after a 165-day review. Its family tree reaches back 3 generations to 1995. 24 later devices descend from it. It has been recalled once.
- Decided
- Dec 13, 2013
- Review
- 165 days
- Class
- Class II
- Product code
- HIH
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 3 generations to K953695 (1995). 7 ancestors in all. 24 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK953695 Dyonics Disposable Arthroscopic BladesSmith & Nephew Dyonics, Inc. · 1995
- 2 generations backK031787 Smith & Nephew Iur Morcellation SystemSmith & Nephew, Inc. · 2003 · Recalled
- 1 generation backK041774 Iur Reciprocating Morcellator Model # 7210517Smith & Nephew, Inc. · 2004
- This deviceK132015 Truclear Morcellation System and Truclear MorcellatorsSmith & Nephew, Inc. · 2013
- Descendant · cites it directly · 14 of its ownK142029 Myosure Hysteroscopic Tissue Removal SystemHologic, Inc. · 2014
- Descendant · 2 generations on · 6 of its ownK152723 Myosure Hysteroscopic Tissue Removal System and Myosure Tissue…Hologic, Inc. · 2015
- Descendant · 3 generations on · 5 of its ownK172566 Myosure Hysteroscopic Tissue Removal System and Myosure Tissue…Hologic, Inc. · 2017
- Descendant · cites it directly · 4 of its ownK190372 Aveta SystemMeditrina, Inc. · 2019
- Descendant · 2 generations on · 4 of its ownK173901 MyoSure MANUAL Tissue Removal DeviceHologic, Inc. · 2018
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 24 · See all- K142029Myosure Hysteroscopic Tissue Removal SystemHologic, Inc. · 2014 · cites it directly14descendants
- K152723Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal DevicesHologic, Inc. · 2015 · 2 generations on6descendants
- K172566Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal DevicesHologic, Inc. · 2017 · 3 generations on5descendants
- K190372Aveta SystemMeditrina, Inc. · 2019 · cites it directly4descendants
- K173901MyoSure MANUAL Tissue Removal DeviceHologic, Inc. · 2018 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K953695 | Dyonics Disposable Arthroscopic Blades | Smith & Nephew Dyonics, Inc. | 1995 | — |
| −2 | K031787 | Smith & Nephew Iur Morcellation System | Smith & Nephew, Inc. | 2003 | 1 |
| −1 | K041774 | Iur Reciprocating Morcellator Model # 7210517 | Smith & Nephew, Inc. | 2004 | — |
| 0 (this device) | K132015 | Truclear Morcellation System and Truclear Morcellators | Smith & Nephew, Inc. | 2013 | — |
| +1 | K142029 | Myosure Hysteroscopic Tissue Removal System | Hologic, Inc. | 2014 | — |
| +2 | K152723 | Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices | Hologic, Inc. | 2015 | — |
| +3 | K172566 | Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices | Hologic, Inc. | 2017 | — |
| +1 | K190372 | Aveta System | Meditrina, Inc. | 2019 | — |
| +2 | K173901 | MyoSure MANUAL Tissue Removal Device | Hologic, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 2011 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K110038 | Truclear Morcellator SystemSummary page 1…l Obstetrics and Gynecological HIH Manufacturer | Description v Submisyslon Clearance - B BN , . . ‘Number - Date . Smith & Nephew, Inc. | TRUCLEAR Morcellator System K110038 03/30/2011 Smith & Nephew, Inc. TRUCLEAR Incisor Plus Blade 2.9 K103389 03/25/2011 Smith & Nephew, Inc. IUR Reciprocating Morcell… | 2011 |
| * | K103389 | Truclear Incisor Plus Blade 2.9Summary page 1…syslon Clearance - B BN , . . ‘Number - Date . Smith & Nephew, Inc. | TRUCLEAR Morcellator System K110038 03/30/2011 Smith & Nephew, Inc. TRUCLEAR Incisor Plus Blade 2.9 K103389 03/25/2011 Smith & Nephew, Inc. IUR Reciprocating Morcellator K041774 10/07/2004 Smith & Nephew, Inc. IUR Morcellation System K03… | 2011 |
| * | K041774 | Iur Reciprocating Morcellator Model # 7210517Summary page 1…TRUCLEAR Morcellator System K110038 03/30/2011 Smith & Nephew, Inc. TRUCLEAR Incisor Plus Blade 2.9 K103389 03/25/2011 Smith & Nephew, Inc. IUR Reciprocating Morcellator K041774 10/07/2004 Smith & Nephew, Inc. IUR Morcellation System K031787 12/02/2003 Device Description Smith & Nephew’'s TRUCLEAR Morcel… | 2004 |
| * | K031787 | Smith & Nephew Iur Morcellation SystemSummary page 1…nc. TRUCLEAR Incisor Plus Blade 2.9 K103389 03/25/2011 Smith & Nephew, Inc. IUR Reciprocating Morcellator K041774 10/07/2004 Smith & Nephew, Inc. IUR Morcellation System K031787 12/02/2003 Device Description Smith & Nephew’'s TRUCLEAR Morcellator System and TRUCLEAR Morcellators use mechanical resection… | 2003 |
What descends from it? (24)
See all 244 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 7, 2022 | Class II | Z-1467-2022 | Device Design | Electrical component failure within the control unit. The observed failure mode is a loss of function of the device when used with handpiece and foot switch. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 2 companies; a new generation was cleared every 8.2 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K142029 (Hologic, Inc., 2014) has gone furthest, with 14 descendants of its own.
How does its category compare?
All HIH devicesHIH Hysteroscope (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 TRUCLEAR System and TRUCLEAR Morcellators are intended for intrauterine use by trained gynecologists to hysteroscopically resect and remove tissue such as: Submucous myomas Endometrial Polyps Retained products of conception
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/K132015 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132015: Truclear Morcellation System and Truclear Morcellators.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132015
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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