510(k) · Cleared
Recalled · Class II · 2022Smith & Nephew Iur Morcellation System
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 2, 2003 as substantially equivalent to K964441 (Gynecare Innovation Center, 1997) and 2 other predicates after a 175-day review. Its family tree reaches back 1 generation to 1995. 37 later devices descend from it. It has been recalled once.
- Decided
- Dec 2, 2003
- Review
- 175 days
- Class
- Class II
- Product code
- HIH
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 1 generation to K953695 (1995). 3 ancestors in all. 37 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK953695 Dyonics Disposable Arthroscopic BladesSmith & Nephew Dyonics, Inc. · 1995
- This deviceK031787 Smith & Nephew Iur Morcellation SystemSmith & Nephew, Inc. · 2003
- Descendant · cites it directly · 34 of its ownK041774 Iur Reciprocating Morcellator Model # 7210517Smith & Nephew, Inc. · 2004
- Descendant · cites it directly · 25 of its ownK110038 Truclear Morcellator SystemSmith & Nephew, Inc. · 2011
- Descendant · cites it directly · 25 of its ownK103389 Truclear Incisor Plus Blade 2.9Smith & Nephew, Inc. · 2011
- Descendant · cites it directly · 24 of its ownK132015 Truclear Morcellation System and Truclear MorcellatorsSmith & Nephew, Inc. · 2013 · Recalled
- Descendant · 2 generations on · 14 of its ownK142029 Myosure Hysteroscopic Tissue Removal SystemHologic, Inc. · 2014
Showing 5 of 37 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 37 · See all- K041774Iur Reciprocating Morcellator Model # 7210517Smith & Nephew, Inc. · 2004 · cites it directly34descendants
- K110038Truclear Morcellator SystemSmith & Nephew, Inc. · 2011 · cites it directly25descendants
- K103389Truclear Incisor Plus Blade 2.9Smith & Nephew, Inc. · 2011 · cites it directly25descendants
- K132015Truclear Morcellation System and Truclear MorcellatorsSmith & Nephew, Inc. · 2013 · cites it directly24descendants
- K142029Myosure Hysteroscopic Tissue Removal SystemHologic, Inc. · 2014 · 2 generations on14descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K953695 | Dyonics Disposable Arthroscopic Blades | Smith & Nephew Dyonics, Inc. | 1995 | — |
| 0 (this device) | K031787 | Smith & Nephew Iur Morcellation System | Smith & Nephew, Inc. | 2003 | — |
| +1 | K041774 | Iur Reciprocating Morcellator Model # 7210517 | Smith & Nephew, Inc. | 2004 | — |
| +1 | K110038 | Truclear Morcellator System | Smith & Nephew, Inc. | 2011 | — |
| +1 | K103389 | Truclear Incisor Plus Blade 2.9 | Smith & Nephew, Inc. | 2011 | — |
| +1 | K132015 | Truclear Morcellation System and Truclear Morcellators | Smith & Nephew, Inc. | 2013 | 1 |
| +2 | K142029 | Myosure Hysteroscopic Tissue Removal System | Hologic, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 3 | 0 |
| 2013 | 3 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K964441 | Femrx Focused Monopolar (Fap) Operastar System [Outpatient Endoscopic Resection and…Summary page 1…Tm scientific technology to the following legally marketed device in commercial distribution: FemRx Focused Monopolar (FMP)ov Star System, K964441. The materials of construction and design are similar to the following legally marketed devices in commercial distribution: D… | 1997 |
| * | K953695 | Dyonics Disposable Arthroscopic BladesSummary page 1…he materials of construction and design are similar to the following legally marketed devices in commercial distribution: Dyonics Disposable Arthroscopic Blades, K953695 and Smith & Nephew Dyonics Power Control Unit, K954989 E. Description of Device The Smith & Nephew IUR Morcellation… | 1995 |
| * | K954989 | Dyonics Disposable Endoscopic Surgery BladesSummary page 1…the following legally marketed devices in commercial distribution: Dyonics Disposable Arthroscopic Blades, K953695 and Smith & Nephew Dyonics Power Control Unit, K954989 E. Description of Device The Smith & Nephew IUR Morcellation System is used to perform hysteroscopic surgery for the… | 1995 |
What descends from it? (37)
See all 374 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?
How does its category compare?
All HIH devicesHIH Hysteroscope (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Smith & Nephew IUR Morcellation System is intended for use in gynecological procedures by trained professional gynocologists to resect and remove endometrial tissue for the following indications, submucous myomas and endometrial polyps.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031787 · printed Nov 5, 2026
Cite this page
510(k) Report. “K031787: Smith & Nephew Iur Morcellation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K031787
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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