510(k) · Cleared
ClearedSmith & Nephew TRUCLEAR ULTRA Mini Tissue Removal Device
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 Nov 22, 2016 as substantially equivalent to K132015 (Smith & Nephew, Inc., 2013) after a 148-day review. Its family tree reaches back 4 generations to 1995.
- Decided
- Nov 22, 2016
- Review
- 148 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. No later device cites it as a predicate yet.
- 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 deviceK161763 Smith & Nephew TRUCLEAR ULTRA Mini Tissue Removal DeviceSmith & Nephew, Inc. · 2016
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) | K161763 | Smith & Nephew TRUCLEAR ULTRA Mini Tissue Removal Device | Smith & Nephew, Inc. | 2016 | — |
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 |
|---|---|---|---|
| * | K132015 | Truclear Morcellation System and Truclear MorcellatorsSummary page 4…HIH (Hysteroscope and accessories) Predicate Device TRUCLEAR ULTRA PLUS Tissue Removal Device (K132015) The predicate device has not been subject to a design… | 2013 |
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 21 years and passes through 2 companies; a new generation was cleared every 8.2 years on median.
- 2 of the 8 ancestors have a recall of any class.
- 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. 2016, 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 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/K161763 · printed Nov 5, 2026
Cite this page
510(k) Report. “K161763: Smith & Nephew TRUCLEAR ULTRA Mini Tissue Removal Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K161763
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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