510(k) · Cleared
ClearedManual Tissue Removal Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Suzhou AcuVu Medical Technology Co., Ltd. · HIH Hysteroscope (And Accessories)
Cleared on May 15, 2026 as substantially equivalent to K173901 (Hologic, Inc., 2018) after a 149-day review. Its family tree reaches back 6 generations to 1995.
- Decided
- May 15, 2026
- Review
- 149 days
- Class
- Class II
- Product code
- HIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K953695 (1995). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK953695 Dyonics Disposable Arthroscopic BladesSmith & Nephew Dyonics, Inc. · 1995
- 5 generations backK031787 Smith & Nephew Iur Morcellation SystemSmith & Nephew, Inc. · 2003 · Recalled
- 4 generations backK041774 Iur Reciprocating Morcellator Model # 7210517Smith & Nephew, Inc. · 2004
- 3 generations backK132015 Truclear Morcellation System and Truclear MorcellatorsSmith & Nephew, Inc. · 2013 · Recalled
- 2 generations backK142029 Myosure Hysteroscopic Tissue Removal SystemHologic, Inc. · 2014
- 1 generation backK173901 MyoSure MANUAL Tissue Removal DeviceHologic, Inc. · 2018
- This deviceK254050 Manual Tissue Removal DeviceSuzhou AcuVu Medical Technology Co., Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K953695 | Dyonics Disposable Arthroscopic Blades | Smith & Nephew Dyonics, Inc. | 1995 | — |
| −5 | K031787 | Smith & Nephew Iur Morcellation System | Smith & Nephew, Inc. | 2003 | 1 |
| −4 | K041774 | Iur Reciprocating Morcellator Model # 7210517 | Smith & Nephew, Inc. | 2004 | — |
| −3 | K132015 | Truclear Morcellation System and Truclear Morcellators | Smith & Nephew, Inc. | 2013 | 1 |
| −2 | K142029 | Myosure Hysteroscopic Tissue Removal System | Hologic, Inc. | 2014 | — |
| −1 | K173901 | MyoSure MANUAL Tissue Removal Device | Hologic, Inc. | 2018 | — |
| 0 (this device) | K254050 | Manual Tissue Removal Device | Suzhou AcuVu Medical Technology Co., Ltd. | 2026 | — |
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? (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 |
|---|---|---|---|
| * | K173901 | MyoSure MANUAL Tissue Removal DeviceSummary page 5…roduct Class: Class II Product Code HIH Panel: Obstetrics/Gynecology III. Predicate Device: MyoSure MANUAL Tissue Removal Device (K173901) The predicate device has not been subject to a design-related recalls. IV. Device Description Manual Tissue Removal 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 31 years and passes through 4 companies; a new generation was cleared every 8.0 years on median.
- 2 of the 10 ancestors have a recall of any class.
- 2 other devices also cite its predicate K173901.
How does its category compare?
All HIH devicesHIH Hysteroscope (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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?
Manual Tissue Removal Device is intended for use to perform tissue resection and removal within uterine cavity, including focal lesions such as polyps and retained products of conception.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K254050 · printed Nov 4, 2026
Cite this page
510(k) Report. “K254050: Manual Tissue Removal Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K254050
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026