510(k) · Cleared
ClearedMyosure XL Tissue Removal Device (1 Pack) Myosure XL Tissue Removal Device (3 Pack)
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 Sep 10, 2012 as substantially equivalent to K100559 (Interlace Medical, Inc., 2010) after a 25-day review. Its family tree reaches back 6 generations to 1995. 1 later device descends from it.
- Decided
- Sep 10, 2012
- Review
- 25 days
- Class
- Class II
- Product code
- HIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K953695 (1995). 9 ancestors in all. 1 later device descends from it, 1 citing it directly.
- 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 backK073690 Interlace Medical Hysteroscopic Morcellation SystemInterlace Medical, Inc. · 2008
- 2 generations backK091100 Myosure Hysteroscopic Tissue Removal SystemInterlace Medical, Inc. · 2009
- 1 generation backK100559 Myosure Hysteroscopic Tissue Removal SystemInterlace Medical, Inc. · 2010
- This deviceK122498 Myosure XL Tissue Removal Device (1 Pack) Myosure XL Tissue Removal…Hologic, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK131736 Myosure Tissue Removal Device (1 Pack), Myosure Tissue Removal…Hologic, Inc. · 2013
Most influential descendants
Showing 1 of 1 · See all- K131736Myosure Tissue Removal Device (1 Pack), Myosure Tissue Removal Device (3 Pack)Hologic, Inc. · 2013 · cites it directly0descendants
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 | K073690 | Interlace Medical Hysteroscopic Morcellation System | Interlace Medical, Inc. | 2008 | — |
| −2 | K091100 | Myosure Hysteroscopic Tissue Removal System | Interlace Medical, Inc. | 2009 | — |
| −1 | K100559 | Myosure Hysteroscopic Tissue Removal System | Interlace Medical, Inc. | 2010 | — |
| 0 (this device) | K122498 | Myosure XL Tissue Removal Device (1 Pack) Myosure XL Tissue Removal Device (3… | Hologic, Inc. | 2012 | — |
| +1 | K131736 | Myosure Tissue Removal Device (1 Pack), Myosure Tissue Removal Device (3 Pack) | Hologic, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 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 |
|---|---|---|---|
| * | K100559 | Myosure Hysteroscopic Tissue Removal SystemSummary page 1…nd accessories Classification Name: Hysteroscope and accessories Class: 11 3. Predicate Device: MyoSureTM Hysteroscopic Tissue Removal System (K100559) 4. Device Description: The modified Myosure Hysteroscopic Tissue Removal System consists of the following pro… | 2010 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K131736 | Myosure Tissue Removal Device (1 Pack), Myosure Tissue Removal Device (3 Pack) | 2013 | 0 |
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 17 years and passes through 4 companies; a new generation was cleared every 2.5 years on median.
- 2 of the 9 ancestors have a recall of any class.
- Of its descendants, K131736 (Hologic, Inc., 2013) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K100559.
How does its category compare?
All HIH devicesHIH Hysteroscope (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 is intended for hysteroscopic intrauterine procedures by a trained gynecologist to resect and remove tissue including submucous myomas and endometrial polyps.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122498 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122498: Myosure XL Tissue Removal Device (1 Pack) Myosure XL Tissue Removal Device (3 Pack).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122498
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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