510(k) · Cleared
ClearedMyosure Tissue Removal Device (1 Pack), Myosure 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 Aug 22, 2013 as substantially equivalent to K122498 (Hologic, Inc., 2012) after a 70-day review. Its family tree reaches back 7 generations to 1995.
- Decided
- Aug 22, 2013
- Review
- 70 days
- Class
- Class II
- Product code
- HIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K953695 (1995). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK953695 Dyonics Disposable Arthroscopic BladesSmith & Nephew Dyonics, Inc. · 1995
- 6 generations backK031787 Smith & Nephew Iur Morcellation SystemSmith & Nephew, Inc. · 2003 · Recalled
- 5 generations backK041774 Iur Reciprocating Morcellator Model # 7210517Smith & Nephew, Inc. · 2004
- 4 generations backK073690 Interlace Medical Hysteroscopic Morcellation SystemInterlace Medical, Inc. · 2008
- 3 generations backK091100 Myosure Hysteroscopic Tissue Removal SystemInterlace Medical, Inc. · 2009
- 2 generations backK100559 Myosure Hysteroscopic Tissue Removal SystemInterlace Medical, Inc. · 2010
- 1 generation backK122498 Myosure XL Tissue Removal Device (1 Pack) Myosure XL Tissue Removal…Hologic, Inc. · 2012
- This deviceK131736 Myosure Tissue Removal Device (1 Pack), Myosure Tissue Removal…Hologic, Inc. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K953695 | Dyonics Disposable Arthroscopic Blades | Smith & Nephew Dyonics, Inc. | 1995 | — |
| −6 | K031787 | Smith & Nephew Iur Morcellation System | Smith & Nephew, Inc. | 2003 | 1 |
| −5 | K041774 | Iur Reciprocating Morcellator Model # 7210517 | Smith & Nephew, Inc. | 2004 | — |
| −4 | K073690 | Interlace Medical Hysteroscopic Morcellation System | Interlace Medical, Inc. | 2008 | — |
| −3 | K091100 | Myosure Hysteroscopic Tissue Removal System | Interlace Medical, Inc. | 2009 | — |
| −2 | K100559 | Myosure Hysteroscopic Tissue Removal System | Interlace Medical, Inc. | 2010 | — |
| −1 | K122498 | Myosure XL Tissue Removal Device (1 Pack) Myosure XL Tissue Removal Device (3… | Hologic, Inc. | 2012 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K122498 | Myosure XL Tissue Removal Device (1 Pack) Myosure XL Tissue Removal Device (3 Pack)Summary page 1…Classification Name: Ilysteroscope and accessories Class: 11 3. Predicate Device: MyoSureiM Hlysteroscopic Tissue Removal System (K 122498) 4. Device Description: The modified Myosure Hysteroscopic Tissue Removal System consists of the following procedu… | 2012 |
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 18 years and passes through 4 companies; a new generation was cleared every 1.5 years on median.
- 2 of the 10 ancestors have a recall of any class.
How does its category compare?
All HIH devicesHIH Hysteroscope (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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/K131736 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131736: Myosure Tissue Removal Device (1 Pack), Myosure 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/K131736
Report an extraction error
Are you the manufacturer?
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