510(k) Report

510(k) · Cleared

Cleared

Myosure Hysteroscopic Tissue Removal System

K100559510(k) SpecialCleared Mar 30, 201029-day reviewClass II21 CFR 884.1690

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Interlace Medical, Inc. · HIH Hysteroscope (And Accessories)

Cleared on Mar 30, 2010 as substantially equivalent to K091100 (Interlace Medical, Inc., 2009) after a 29-day review. Its family tree reaches back 5 generations to 1995. 6 later devices descend from it.

Decided
Mar 30, 2010
Review
29 days
Class
Class II
Product code
HIH
Recalls
None
Predicates
1

Its longest line of descent runs back 5 generations to K953695 (1995). 8 ancestors in all. 6 later devices descend from it, 5 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2006: 1 other ancestor1997: 1 other ancestor1995: 1 other ancestor2012: 3 descendants cleared2013: 2 descendants cleared2011: 1 descendant clearedK953695 · Dyonics Disposable Arthroscopic Blades · Smith & Nephew Dyonics, Inc. · 1995K031787 · Smith & Nephew Iur Morcellation System · Smith & Nephew, Inc. · 2003 · recalledK041774 · Iur Reciprocating Morcellator Model # 7210517 · Smith & Nephew, Inc. · 2004K073690 · Interlace Medical Hysteroscopic Morcellation System · Interlace Medical, Inc. · 2008K091100 · Myosure Hysteroscopic Tissue Removal System · Interlace Medical, Inc. · 20091995200020052010201520202025
Other ancestors, by generationDescendants, by generation 2 generations back: 1 other ancestor5 generations back: 2 other ancestors 1 generation forward: 5 descendants2 generations forward: 1 descendant K091100 · Myosure Hysteroscopic Tissue Removal System · Interlace Medical, Inc. · 2009K073690 · Interlace Medical Hysteroscopic Morcellation System · Interlace Medical, Inc. · 2008K041774 · Iur Reciprocating Morcellator Model # 7210517 · Smith & Nephew, Inc. · 2004K031787 · Smith & Nephew Iur Morcellation System · Smith & Nephew, Inc. · 2003 · recalledK953695 · Dyonics Disposable Arthroscopic Blades · Smith & Nephew Dyonics, Inc. · 1995−50
  1. Root · 5 generations backK953695 Dyonics Disposable Arthroscopic BladesSmith & Nephew Dyonics, Inc. · 1995
  2. 4 generations backK031787 Smith & Nephew Iur Morcellation SystemSmith & Nephew, Inc. · 2003 · Recalled
  3. 3 generations backK041774 Iur Reciprocating Morcellator Model # 7210517Smith & Nephew, Inc. · 2004
  4. 2 generations backK073690 Interlace Medical Hysteroscopic Morcellation SystemInterlace Medical, Inc. · 2008
  5. 1 generation backK091100 Myosure Hysteroscopic Tissue Removal SystemInterlace Medical, Inc. · 2009
  6. This deviceK100559 Myosure Hysteroscopic Tissue Removal SystemInterlace Medical, Inc. · 2010
  7. Descendant · cites it directly · 1 of its ownK122498 Myosure XL Tissue Removal Device (1 Pack) Myosure XL Tissue Removal…Hologic, Inc. · 2012
  8. Descendant · cites it directly · 0 of its ownK131581 Myosure Tissue Removal Device (1 Pack and 3 Pack)Hologic, Inc. · 2013
  9. Descendant · 2 generations on · 0 of its ownK131736 Myosure Tissue Removal Device (1 Pack), Myosure Tissue Removal…Hologic, Inc. · 2013
  10. Descendant · cites it directly · 0 of its ownK121868 Myosure Lite Tissue Removal Device (1 Pack), Myosure Lite Tissue…Hologic, Inc. · 2012
  11. Descendant · cites it directly · 0 of its ownK120593 Myosure Control UnitHologic, Inc. · 2012

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2011: 12012: 32013: 2
2011high 3 (2012) · low 0 (2014)2026

Most influential descendants

Showing 5 of 6 · See all
  • K122498Myosure XL Tissue Removal Device (1 Pack) Myosure XL Tissue Removal Device (3 Pack)Hologic, Inc. · 2012 · cites it directly1descendant
  • K131581Myosure Tissue Removal Device (1 Pack and 3 Pack)Hologic, Inc. · 2013 · cites it directly0descendants
  • K131736Myosure Tissue Removal Device (1 Pack), Myosure Tissue Removal Device (3 Pack)Hologic, Inc. · 2013 · 2 generations on0descendants
  • K121868Myosure Lite Tissue Removal Device (1 Pack), Myosure Lite Tissue Removal Device (3 Pack)Hologic, Inc. · 2012 · cites it directly0descendants
  • K120593Myosure Control UnitHologic, Inc. · 2012 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K953695Dyonics Disposable Arthroscopic BladesSmith & Nephew Dyonics, Inc.1995—
−4K031787Smith & Nephew Iur Morcellation SystemSmith & Nephew, Inc.20031
−3K041774Iur Reciprocating Morcellator Model # 7210517Smith & Nephew, Inc.2004—
−2K073690Interlace Medical Hysteroscopic Morcellation SystemInterlace Medical, Inc.2008—
−1K091100Myosure Hysteroscopic Tissue Removal SystemInterlace Medical, Inc.2009—
0 (this device)K100559Myosure Hysteroscopic Tissue Removal SystemInterlace Medical, Inc.2010—
+1K122498Myosure XL Tissue Removal Device (1 Pack) Myosure XL Tissue Removal Device (3…Hologic, Inc.2012—
+1K131581Myosure Tissue Removal Device (1 Pack and 3 Pack)Hologic, Inc.2013—
+2K131736Myosure Tissue Removal Device (1 Pack), Myosure Tissue Removal Device (3 Pack)Hologic, Inc.2013—
+1K121868Myosure Lite Tissue Removal Device (1 Pack), Myosure Lite Tissue Removal…Hologic, Inc.2012—
+1K120593Myosure Control UnitHologic, Inc.2012—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199510
199710
200610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201110
201230
201320
FIG. 1 — Lineage of K100559, 1995–2013Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K232003 Endoscopic Video Image Processor, Single-Use…score 16.1 · 12 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K091100Myosure Hysteroscopic Tissue Removal System
Summary page 1
…s Classification Name: Hysteroscope and accessories Class: II 3. Predicate Device: MyoSure Tm Hysteroscopic Tissue Removal System (K091 100) 4. Device Description: The modified MyoSure Hysteroscopic Tissue Removal System consists of the foll…
Interlace Medical, Inc.2009—

Also cleared against K091100: 1 other device →

What descends from it? (6)

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K122498Myosure XL Tissue Removal Device (1 Pack) Myosure XL Tissue Removal Device (3 Pack)Hologic, Inc.20121
K131581Myosure Tissue Removal Device (1 Pack and 3 Pack)Hologic, Inc.20130
K121868Myosure Lite Tissue Removal Device (1 Pack), Myosure Lite Tissue Removal Device (3 Pack)Hologic, Inc.20120
K120593Myosure Control UnitHologic, Inc.20120
K103741Surgisure Tissue Removal SystemInterlace Medical, Inc.20110

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 15 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
  • 2 of the 8 ancestors have a recall of any class.
  • Of its descendants, K122498 (Hologic, Inc., 2012) has gone furthest, with 1 descendant of its own.
  • 1 other device also cites its predicate K091100.

How does its category compare?

All HIH devices

HIH Hysteroscope (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · HIH

3in 2025

2007: 12008: 22009: 42010: 42011: 32012: 42013: 52014: 22015: 52016: 32017: 22018: 82019: 142020: 72021: 42022: 22023: 42024: 62025: 32026 (partial year): 7
2007high 14 (2019) · low 1 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HIH

111in 2025

2009: 130 days median2010: 109 days median2011: 118 days median2012: 25 days median2013: 144 days median2015: 52 days median2016: 106 days median2018: 135 days median2019: 91 days median2020: 88 days median2021: 194 days median2023: 200 days median2024: 148 days median2025: 111 days median2026 (partial year): 168 days median
2007high 200 (2023) · low 25 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HIH

3so far in 2026, the most since 2007

2019: 12023: 22026 (partial year): 3
2007high 3 (2026) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HIH

1,698in 2025

2007: 72008: 122009: 172010: 312011: 592012: 782013: 1112014: 1252015: 2112016: 1722017: 3362018: 1822019: 2202020: 2532021: 1932022: 2892023: 1,4492024: 1,6112025: 1,698
2007high 1,698 (2025) · low 7 (2007)2025

MAUDE reports naming product code HIH, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—07
20082—012
20094130017
20104109031
20113118059
2012425078
201351440111
20142—0125
20155520211
201631060172
20172—0336
201881350182
201914911220
20207880253
202141940193
20222—0289
2023420021,449
2024614801,611
2025311101,698
202671683—

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.

Also cleared against K091100

1 other device cites the same predicate.

  • K103741Surgisure Tissue Removal SystemInterlace Medical, Inc. · 2011

More from Interlace Medical, Inc.

7 FDA decisions under this applicant name. See the company

  • K103741Surgisure Tissue Removal SystemInterlace Medical, Inc. · 2011
  • K102686Myosure Rod Lens Scope SealsInterlace Medical, Inc. · 2010
  • K091100Myosure Hysteroscopic Tissue Removal SystemInterlace Medical, Inc. · 2009
  • K091465Myosure Rod Lens HysteroscopeInterlace Medical, Inc. · 2009
  • K081070Interlace Medical Operative Hysteroscopy SystemInterlace Medical, Inc. · 2008

Recent decisions in HIH

The HIH category page

  • K254252UNIDRIVE SIII System; HOPKINS Telescope 0º (26205AMA) Operating Sheath (26205CD) Obturator (26205OC) Shaver…Karl Storz SE & CO. KG · 2026
  • K261102UNIDRIVE Select SystemKarl Storz SE & CO. KG · 2026
  • K254294Single-use Digital Hysteroscope (GYUT-A 12.6- 0, GYUT-A12.6- 12, GYUT-A 12.6- 22, GYUT-A 12.6- 30, GYUT-A…Zhejiang Geyi Medical Instrument Co., Ltd. · 2026
  • K260984HERizon RD5 Resecting Device (5FR1PK);HERizon RD5 Resecting Device - 5 pack (5FR5PK)Axora Medical, Inc. · 2026
  • K253020Strauss Surgical Resection InstrumentsAmerican Medical Endoscopy, Inc. · 2026

https://510kreport.com/device/K100559 · printed Nov 6, 2026

Cite this page

510(k) Report. “K100559: Myosure Hysteroscopic Tissue Removal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100559

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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