510(k) · Cleared
ClearedReprocessed MyoSure Tissue Removal Device, Reprocessed MyoSure REACH Tissue Removal Device, Reprocessed MyoSure LITE Tissue Removal Device, Reprocessed MyoSure XL Tissue Removal Device, Reprocessed MyoSure XL Tissue Removal Device for Fluent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Sustainability Solutions · HIH Hysteroscope (And Accessories)
Cleared on Sep 25, 2020 as substantially equivalent to K172566 (Hologic, Inc., 2017) and 2 other predicates after an 88-day review. Its family tree reaches back 8 generations to 1995.
- Decided
- Sep 25, 2020
- Review
- 88 days
- Class
- Class II
- Product code
- HIH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K953695 (1995). 12 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK953695 Dyonics Disposable Arthroscopic BladesSmith & Nephew Dyonics, Inc. · 1995
- 7 generations backK031787 Smith & Nephew Iur Morcellation SystemSmith & Nephew, Inc. · 2003 · Recalled
- 6 generations backK041774 Iur Reciprocating Morcellator Model # 7210517Smith & Nephew, Inc. · 2004
- 5 generations backK132015 Truclear Morcellation System and Truclear MorcellatorsSmith & Nephew, Inc. · 2013 · Recalled
- 4 generations backK142029 Myosure Hysteroscopic Tissue Removal SystemHologic, Inc. · 2014
- 3 generations backK152723 Myosure Hysteroscopic Tissue Removal System and Myosure Tissue…Hologic, Inc. · 2015
- 2 generations backK172566 Myosure Hysteroscopic Tissue Removal System and Myosure Tissue…Hologic, Inc. · 2017
- 1 generation backK181974 MyoSure XL Tissue Removal Device for FluentHologic, Inc. · 2018
- This deviceK201756 Reprocessed MyoSure Tissue Removal Device, Reprocessed MyoSure REACH…Stryker Sustainability Solutions · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K953695 | Dyonics Disposable Arthroscopic Blades | Smith & Nephew Dyonics, Inc. | 1995 | — |
| −7 | K031787 | Smith & Nephew Iur Morcellation System | Smith & Nephew, Inc. | 2003 | 1 |
| −6 | K041774 | Iur Reciprocating Morcellator Model # 7210517 | Smith & Nephew, Inc. | 2004 | — |
| −5 | K132015 | Truclear Morcellation System and Truclear Morcellators | Smith & Nephew, Inc. | 2013 | 1 |
| −4 | K142029 | Myosure Hysteroscopic Tissue Removal System | Hologic, Inc. | 2014 | — |
| −3 | 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 | K181974 | MyoSure XL Tissue Removal Device for Fluent | Hologic, Inc. | 2018 | — |
| 0 (this device) | K201756 | Reprocessed MyoSure Tissue Removal Device, Reprocessed MyoSure REACH Tissue… | Stryker Sustainability Solutions | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 2011 | 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? (3)
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 |
|---|---|---|---|
| * | K172566 | Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal DevicesSummary page 4…Number Manufacturer 10-401 MyoSure Hysteroscopic Tissue Removal System K172566 Hologic, Inc. 10-403 and MyoSure Tissue Removal Device… | 2017 |
| * | K152723 | Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal DevicesSummary page 4…Hologic, Inc. 10-403 and MyoSure Tissue Removal Devices 10-401FC MyoSure Hysteroscopic Tissue Removal System K152723 Hologic, Inc. 10-403FC and MyoSure Tissue Removal Device… | 2015 |
| * | K181974 | MyoSure XL Tissue Removal Device for FluentSummary page 4…K172566 Hologic, Inc. 50-503XL and MyoSure Tissue Removal Devices 50-601XL K181974 MyoSure XL Tissue Removal Device for Fluent Hologic, Inc. 50-603XL The predicate devices have not been subject to a de… | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
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 25 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
- 2 of the 12 ancestors have a recall of any class.
- 2 other devices also cite its predicate K172566.
How does its category compare?
All HIH devicesHIH Hysteroscope (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 Reprocessed MyoSure Tissue Removal Device (Model# 10-401/10-403) is indicated for intrauterine use by trained gynecologists to hysteroscopically resect and remove tissue such as: submucous myomas, endometrial polyps, and retained products of conception. The Reprocessed MyoSure REACH Tissue Removal Device (Model# 10-401FC/10-403FC) is indicated for intrauterine use by trained gynecologists to hysteroscopically resect and remove tissue such as…
Read the full statement (174 words)
The Reprocessed MyoSure Tissue Removal Device (Model# 10-401/10-403) is indicated for intrauterine use by trained gynecologists to hysteroscopically resect and remove tissue such as: submucous myomas, endometrial polyps, and retained products of conception.
The Reprocessed MyoSure REACH Tissue Removal Device (Model# 10-401FC/10-403FC) is indicated for intrauterine use by trained gynecologists to hysteroscopically resect and remove tissue such as: submucous myomas, endometrial polyps, and retain products of conception.
The Reprocessed MyoSure LITE Tissue Removal Device (Model # 30-40 I LITE/30-403LITE) is indicated for intrauterine use by trained gynecologists to hysteroscopically resect and remove tissue such as: submucous myomas, endometrial polyps, and retain products of conception.
The Reprocessed MyoSure XL Tissue Removal Device (Model# 50-501XL/50-503XL) is indicated for intrauterine use by trained gynecologists to hysteroscopically resect and remove tissue such as: submucous myomas, endometrial polyps, and retain products of conception.
The Reprocessed MyoSure XL Tissue Removal Device for Fluent (Model# 50-601XL/50-603XL) is indicated for intrauterine use by trained gynecologists to hysteroscopically resect and remove tissue such as: submucous myomas, endometrial polyps, and retain products of conception.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201756 · printed Nov 3, 2026
Cite this page
510(k) Report. “K201756: Reprocessed MyoSure Tissue Removal Device, Reprocessed MyoSure REACH Tissue Removal Device, Reprocessed MyoSure LITE Tissue Removal Device, Reprocessed MyoSure XL Tissue Removal Device, Reprocessed MyoSure XL Tissue Removal Device for Fluent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K201756
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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