510(k) · Cleared
ClearedMyosure Hysteroscopic Tissue Removal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hologic, Inc. · HIH Hysteroscope (And Accessories)
Cleared on Nov 26, 2014 as substantially equivalent to K132015 (Smith & Nephew, Inc., 2013) after a 124-day review. Its family tree reaches back 4 generations to 1995. 14 later devices descend from it.
- Decided
- Nov 26, 2014
- Review
- 124 days
- Class
- Class II
- Product code
- HIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K953695 (1995). 8 ancestors in all. 14 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK953695 Dyonics Disposable Arthroscopic BladesSmith & Nephew Dyonics, Inc. · 1995
- 3 generations backK031787 Smith & Nephew Iur Morcellation SystemSmith & Nephew, Inc. · 2003 · Recalled
- 2 generations backK041774 Iur Reciprocating Morcellator Model # 7210517Smith & Nephew, Inc. · 2004
- 1 generation backK132015 Truclear Morcellation System and Truclear MorcellatorsSmith & Nephew, Inc. · 2013 · Recalled
- This deviceK142029 Myosure Hysteroscopic Tissue Removal SystemHologic, Inc. · 2014
- Descendant · cites it directly · 6 of its ownK152723 Myosure Hysteroscopic Tissue Removal System and Myosure Tissue…Hologic, Inc. · 2015
- Descendant · 2 generations on · 5 of its ownK172566 Myosure Hysteroscopic Tissue Removal System and Myosure Tissue…Hologic, Inc. · 2017
- Descendant · cites it directly · 4 of its ownK173901 MyoSure MANUAL Tissue Removal DeviceHologic, Inc. · 2018
- Descendant · 3 generations on · 2 of its ownK180825 Fluent Fluid Management SystemHologic, Inc. · 2018
- Descendant · 2 generations on · 1 of its ownK191538 Resectr Tissue Resection DeviceBoston Scientific Corporation · 2020
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K152723Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal DevicesHologic, Inc. · 2015 · cites it directly6descendants
- K172566Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal DevicesHologic, Inc. · 2017 · 2 generations on5descendants
- K173901MyoSure MANUAL Tissue Removal DeviceHologic, Inc. · 2018 · cites it directly4descendants
- K180825Fluent Fluid Management SystemHologic, Inc. · 2018 · 3 generations on2descendants
- K191538Resectr Tissue Resection DeviceBoston Scientific Corporation · 2020 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K953695 | Dyonics Disposable Arthroscopic Blades | Smith & Nephew Dyonics, Inc. | 1995 | — |
| −3 | K031787 | Smith & Nephew Iur Morcellation System | Smith & Nephew, Inc. | 2003 | 1 |
| −2 | K041774 | Iur Reciprocating Morcellator Model # 7210517 | Smith & Nephew, Inc. | 2004 | — |
| −1 | K132015 | Truclear Morcellation System and Truclear Morcellators | Smith & Nephew, Inc. | 2013 | 1 |
| 0 (this device) | K142029 | Myosure Hysteroscopic Tissue Removal System | Hologic, Inc. | 2014 | — |
| +1 | K152723 | Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices | Hologic, Inc. | 2015 | — |
| +2 | K172566 | Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices | Hologic, Inc. | 2017 | — |
| +1 | K173901 | MyoSure MANUAL Tissue Removal Device | Hologic, Inc. | 2018 | — |
| +3 | K180825 | Fluent Fluid Management System | Hologic, Inc. | 2018 | — |
| +2 | K191538 | Resectr Tissue Resection Device | Boston Scientific Corporation | 2020 | — |
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 |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2024 | 2 | 0 |
| 2026 | 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 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 |
|---|---|---|---|
| * | K132015 | Truclear Morcellation System and Truclear MorcellatorsSummary page 4…cope and accessories (21 CFR 884.1690, Product Code HIH) Class: II 3. Predicate Device: TRUCLEAR Morcellator System and TRUCLEAR Morcellators (K132015) 4. Device Description: The Myosure Hysteroscopic Tissue Removal System consists of the following procedural c… | 2013 |
What descends from it? (14)
See all 143 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?
- The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 8.2 years on median.
- 2 of the 8 ancestors have a recall of any class.
- Of its descendants, K152723 (Hologic, Inc., 2015) has gone furthest, with 6 descendants of its own.
- 3 other devices also cite its predicate K132015.
How does its category compare?
All HIH devicesHIH Hysteroscope (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices 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 as stated in the FDA summary.
https://510kreport.com/device/K142029 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142029: Myosure Hysteroscopic Tissue Removal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142029
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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