510(k) Report

510(k) · Cleared

Cleared

Interlace Medical Hysteroscopic Morcellation System

K073690510(k) TraditionalCleared Apr 17, 2008111-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 Apr 17, 2008 as substantially equivalent to K041774 (Smith & Nephew, Inc., 2004) after a 111-day review. Its family tree reaches back 3 generations to 1995. 8 later devices descend from it.

Decided
Apr 17, 2008
Review
111 days
Class
Class II
Product code
HIH
Recalls
None
Predicates
1

Its longest line of descent runs back 3 generations to K953695 (1995). 5 ancestors in all. 8 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1997: 1 other ancestor1995: 1 other ancestor2009: 1 descendant cleared2011: 1 descendant cleared2010: 1 descendant cleared2012: 3 descendants cleared2013: 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. · 20041995200020052010201520202025
Other ancestors, by generationDescendants, by generation 3 generations back: 2 other ancestors 1 generation forward: 1 descendant2 generations forward: 2 descendants3 generations forward: 4 descendants4 generations forward: 1 descendant K041774 · 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. · 19950
  1. Root · 3 generations backK953695 Dyonics Disposable Arthroscopic BladesSmith & Nephew Dyonics, Inc. · 1995
  2. 2 generations backK031787 Smith & Nephew Iur Morcellation SystemSmith & Nephew, Inc. · 2003 · Recalled
  3. 1 generation backK041774 Iur Reciprocating Morcellator Model # 7210517Smith & Nephew, Inc. · 2004
  4. This deviceK073690 Interlace Medical Hysteroscopic Morcellation SystemInterlace Medical, Inc. · 2008
  5. Descendant · cites it directly · 7 of its ownK091100 Myosure Hysteroscopic Tissue Removal SystemInterlace Medical, Inc. · 2009
  6. Descendant · 2 generations on · 6 of its ownK100559 Myosure Hysteroscopic Tissue Removal SystemInterlace Medical, Inc. · 2010
  7. Descendant · 3 generations on · 1 of its ownK122498 Myosure XL Tissue Removal Device (1 Pack) Myosure XL Tissue Removal…Hologic, Inc. · 2012
  8. Descendant · 3 generations on · 0 of its ownK131581 Myosure Tissue Removal Device (1 Pack and 3 Pack)Hologic, Inc. · 2013
  9. Descendant · 4 generations on · 0 of its ownK131736 Myosure Tissue Removal Device (1 Pack), Myosure Tissue Removal…Hologic, Inc. · 2013

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2009: 12010: 12011: 12012: 32013: 2
2009high 3 (2012) · low 0 (2014)2026

Most influential descendants

Showing 5 of 8 · See all
  • K091100Myosure Hysteroscopic Tissue Removal SystemInterlace Medical, Inc. · 2009 · cites it directly7descendants
  • K100559Myosure Hysteroscopic Tissue Removal SystemInterlace Medical, Inc. · 2010 · 2 generations on6descendants
  • K122498Myosure XL Tissue Removal Device (1 Pack) Myosure XL Tissue Removal Device (3 Pack)Hologic, Inc. · 2012 · 3 generations on1descendant
  • K131581Myosure Tissue Removal Device (1 Pack and 3 Pack)Hologic, Inc. · 2013 · 3 generations on0descendants
  • K131736Myosure Tissue Removal Device (1 Pack), Myosure Tissue Removal Device (3 Pack)Hologic, Inc. · 2013 · 4 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

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

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199510
199710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201010
201110
201230
201320
FIG. 1 — Lineage of K073690, 1995–2013Source: 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
*K041774Iur Reciprocating Morcellator Model # 7210517
Summary page 1
…ice The Interlace Medical Hysteroscopic Morcellation System is substantially equivalent to the Smith and Nephew Hysteroscopic Morcellation System K04 1774. 4. Device Description The system consists of the following components: o Control Unit o…
Smith & Nephew, Inc.2004—

Also cleared against K041774: 1 other device →

What descends from it? (8)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K091100Myosure Hysteroscopic Tissue Removal SystemInterlace Medical, Inc.20097

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 13 years and passes through 3 companies; a new generation was cleared every 3.5 years on median.
  • 1 of the 5 ancestors has a recall of any class.
  • Of its descendants, K091100 (Interlace Medical, Inc., 2009) has gone furthest, with 7 descendants of its own.
  • 1 other device also cites its predicate K041774.

How does its category compare?

All HIH devices

HIH Hysteroscope (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 Interlace Medical Hysteroscopic Morcellation 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 K041774

1 other device cites the same predicate.

  • K132015Truclear Morcellation System and Truclear MorcellatorsSmith & Nephew, Inc. · 20131 recall

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
  • K100559Myosure Hysteroscopic Tissue Removal SystemInterlace Medical, Inc. · 2010
  • K091100Myosure Hysteroscopic Tissue Removal SystemInterlace Medical, Inc. · 2009
  • K091465Myosure Rod Lens HysteroscopeInterlace Medical, Inc. · 2009

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/K073690 · printed Nov 5, 2026

Cite this page

510(k) Report. “K073690: Interlace Medical Hysteroscopic 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/K073690

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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