510(k) Report

510(k) · Cleared

Cleared

Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices

K152723510(k) SpecialCleared Nov 13, 201552-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

Hologic, Inc. · HIH Hysteroscope (And Accessories)

Cleared on Nov 13, 2015 as substantially equivalent to K142029 (Hologic, Inc., 2014) after a 52-day review. Its family tree reaches back 5 generations to 1995. 6 later devices descend from it.

Decided
Nov 13, 2015
Review
52 days
Class
Class II
Product code
HIH
Recalls
None
Predicates
1

Its longest line of descent runs back 5 generations to K953695 (1995). 9 ancestors in all. 6 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2011: 2 other ancestors1997: 1 other ancestor1995: 1 other ancestor2020: 1 descendant cleared2017: 1 descendant cleared2018: 2 descendants cleared2024: 2 descendants 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. · 2004K132015 · Truclear Morcellation System and Truclear Morcellators · Smith & Nephew, Inc. · 2013 · recalledK142029 · Myosure Hysteroscopic Tissue Removal System · Hologic, Inc. · 20141995200020052010201520202025
Other ancestors, by generationDescendants, by generation 3 generations back: 2 other ancestors4 generations back: 2 other ancestors 1 generation forward: 2 descendants2 generations forward: 2 descendants3 generations forward: 2 descendants K142029 · Myosure Hysteroscopic Tissue Removal System · Hologic, Inc. · 2014K132015 · Truclear Morcellation System and Truclear Morcellators · Smith & Nephew, Inc. · 2013 · recalledK041774 · 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 backK132015 Truclear Morcellation System and Truclear MorcellatorsSmith & Nephew, Inc. · 2013 · Recalled
  5. 1 generation backK142029 Myosure Hysteroscopic Tissue Removal SystemHologic, Inc. · 2014
  6. This deviceK152723 Myosure Hysteroscopic Tissue Removal System and Myosure Tissue…Hologic, Inc. · 2015
  7. Descendant · cites it directly · 5 of its ownK172566 Myosure Hysteroscopic Tissue Removal System and Myosure Tissue…Hologic, Inc. · 2017
  8. Descendant · 2 generations on · 2 of its ownK180825 Fluent Fluid Management SystemHologic, Inc. · 2018
  9. Descendant · 2 generations on · 1 of its ownK181974 MyoSure XL Tissue Removal Device for FluentHologic, Inc. · 2018
  10. Descendant · 3 generations on · 0 of its ownK240886 Fluent Pro Fluid Management System (FLT-200); Fluent Pro Fluid…Hologic, Inc. · 2024
  11. Descendant · 3 generations on · 0 of its ownK233710 Symphion Operative Hysteroscopy SystemMinerva Surgical, Inc. · 2024

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2017: 12018: 22020: 12024: 2
2017high 2 (2018) · low 0 (2019)2026

Most influential descendants

Showing 5 of 6 · See all
  • K172566Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal DevicesHologic, Inc. · 2017 · cites it directly5descendants
  • K180825Fluent Fluid Management SystemHologic, Inc. · 2018 · 2 generations on2descendants
  • K181974MyoSure XL Tissue Removal Device for FluentHologic, Inc. · 2018 · 2 generations on1descendant
  • K240886Fluent Pro Fluid Management System (FLT-200); Fluent Pro Fluid Management System…Hologic, Inc. · 2024 · 3 generations on0descendants
  • K233710Symphion Operative Hysteroscopy SystemMinerva Surgical, Inc. · 2024 · 3 generations on0descendants
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—
−2K132015Truclear Morcellation System and Truclear MorcellatorsSmith & Nephew, Inc.20131
−1K142029Myosure Hysteroscopic Tissue Removal SystemHologic, Inc.2014—
0 (this device)K152723Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal DevicesHologic, Inc.2015—
+1K172566Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal DevicesHologic, Inc.2017—
+2K180825Fluent Fluid Management SystemHologic, Inc.2018—
+2K181974MyoSure XL Tissue Removal Device for FluentHologic, Inc.2018—
+3K240886Fluent Pro Fluid Management System (FLT-200); Fluent Pro Fluid Management…Hologic, Inc.2024—
+3K233710Symphion Operative Hysteroscopy SystemMinerva Surgical, Inc.2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199510
199710
201120

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201710
201820
202010
202420
FIG. 1 — Lineage of K152723, 1995–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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
*K142029Myosure Hysteroscopic Tissue Removal System
Summary page 4
…ecology Predicate Device: Trade name: Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices Submitter / 510(k) Holder: Hologic, Inc. 510(k) #: K142029 Classification code: HIH and Regulation: 21.CFR.884.1690 DEVICE DESCRIPTION The Myosure Hysteroscopic Tissue Removal System co…
Hologic, Inc.2014—

Also cleared against K142029: 2 other devices →

What descends from it? (6)

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

NumberDeviceApplicantDecidedDescendants
K172566Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal DevicesHologic, Inc.20175
K201756Reprocessed MyoSure Tissue Removal Device, Reprocessed MyoSure REACH Tissue Removal…Stryker Sustainability Solutions20200

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 20 years and passes through 3 companies; a new generation was cleared every 12 months on median.
  • 2 of the 9 ancestors have a recall of any class.
  • Of its descendants, K172566 (Hologic, Inc., 2017) has gone furthest, with 5 descendants of its own.
  • 2 other devices also cite its predicate K142029.

How does its category compare?

All HIH devices

HIH Hysteroscope (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 Tissue Removal System and 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.

Also cleared against K142029

2 other devices cite the same predicate.

  • K173901MyoSure MANUAL Tissue Removal DeviceHologic, Inc. · 2018
  • K170120EndoRotorInterscope, Inc. · 2017

More from Hologic, Inc.

463 FDA decisions under this applicant name. See the company

  • K254090I-View®Hologic, Inc. · 2026
  • P920048/S030Rapid fFN for the TLiIQ SystemHologic, Inc. · 2026
  • K262792Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09)Hologic, Inc. · 2026
  • K253634CoolSeal Generator® (CSL-200-90)Hologic, Inc. · 2026
  • P920048/S028Rapid fFN for the TLiIQ SystemHologic, Inc. · 2026

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/K152723 · printed Nov 6, 2026

Cite this page

510(k) Report. “K152723: Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152723

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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