510(k) Report

510(k) · Cleared

Cleared

Myosure Rod Lens Hysteroscope

K091465510(k) TraditionalCleared Aug 21, 200995-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 Aug 21, 2009 as substantially equivalent to K941541 (Henke Sass Wolf of America, Inc., 1994) and 4 other predicates after a 95-day review. Its family tree reaches back 2 generations to 1995. 4 later devices descend from it.

Decided
Aug 21, 2009
Review
95 days
Class
Class II
Product code
HIH
Recalls
None
Predicates
5

Its longest line of descent runs back 2 generations to K954050 (1995). 8 ancestors in all, the oldest K941541 (1994). 4 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2004: 1 other ancestor2002: 1 other ancestor1996: 1 other ancestor1994: 1 other ancestor2000: 1 other ancestor1997: 1 other ancestor2010: 1 descendant cleared2018: 1 descendant cleared2012: 1 descendant cleared2019: 1 descendant clearedReference device: K081070 · Interlace Medical Operative Hysteroscopy System · Interlace Medical, Inc. · 2008K954050 · Resectoscopes · KARL STORZ Endoscopy-America, Inc. · 1995K991563 · Continuous Flow Hystero-Resectoscope, Knife Electrode, Spike Electrode, Vaporisation Electrode, Coagulation Electrode, C · Henke Sass Wolf of America, Inc. · 19991990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors2 generations back: 2 other ancestors 1 generation forward: 3 descendants2 generations forward: 1 descendant K991563 · Continuous Flow Hystero-Resectoscope, Knife Electrode, Spike Electrode, Vaporisation Electrode, Coagulation Electrode, C · Henke Sass Wolf of America, Inc. · 1999K954050 · Resectoscopes · KARL STORZ Endoscopy-America, Inc. · 19950
  1. Root · 2 generations backK954050 ResectoscopesKARL STORZ Endoscopy-America, Inc. · 1995
  2. 1 generation backK991563 Continuous Flow Hystero-Resectoscope, Knife Electrode, Spike…Henke Sass Wolf of America, Inc. · 1999
  3. This deviceK091465 Myosure Rod Lens HysteroscopeInterlace Medical, Inc. · 2009
  4. Descendant · cites it directly · 2 of its ownK122563 Myosure XL Rod Lens Hysteroscope, Myosure XL Outlfow ChannelHologic, Inc. · 2012
  5. Descendant · cites it directly · 1 of its ownK182006 Omni Hysteroscope, Omni Hysteroscope Kits, Omni SheathsHologic, Inc. · 2018
  6. Descendant · 2 generations on · 0 of its ownK191281 Omni Hysteroscope, Omni Lok cervical sealHologic, Inc. · 2019
  7. Descendant · cites it directly · 0 of its ownK102686 Myosure Rod Lens Scope SealsInterlace Medical, Inc. · 2010

Most influential descendants

Showing 4 of 4 · See all
  • K122563Myosure XL Rod Lens Hysteroscope, Myosure XL Outlfow ChannelHologic, Inc. · 2012 · cites it directly2descendants
  • K182006Omni Hysteroscope, Omni Hysteroscope Kits, Omni SheathsHologic, Inc. · 2018 · cites it directly1descendant
  • K191281Omni Hysteroscope, Omni Lok cervical sealHologic, Inc. · 2019 · 2 generations on0descendants
  • K102686Myosure Rod Lens Scope SealsInterlace Medical, Inc. · 2010 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K954050ResectoscopesKARL STORZ Endoscopy-America, Inc.1995—
−1K991563Continuous Flow Hystero-Resectoscope, Knife Electrode, Spike Electrode…Henke Sass Wolf of America, Inc.1999—
0 (this device)K091465Myosure Rod Lens HysteroscopeInterlace Medical, Inc.2009—
+1K122563Myosure XL Rod Lens Hysteroscope, Myosure XL Outlfow ChannelHologic, Inc.2012—
+1K182006Omni Hysteroscope, Omni Hysteroscope Kits, Omni SheathsHologic, Inc.2018—
+2K191281Omni Hysteroscope, Omni Lok cervical sealHologic, Inc.2019—
+1K102686Myosure Rod Lens Scope SealsInterlace Medical, Inc.2010—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410
199610
199710
200010
200210
200410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
201210
201810
201910
FIG. 1 — Lineage of K091465, 1995–2019Source: 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? (5)

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
*K941541HSV Laparoscopy Set
Summary page 1
…ysteroscope and accessories Class: II 3. Predicate Device: Henke Sass Wolf Hysteroscopes, Hysteroscopic Resecto scopes and Accessories (K941541 I K952186 / K991563) Smith & Nephew Hysteroscope and Accessories (K013 870) Stryker Urology and Gynecology Hardw…
Henke Sass Wolf of America, Inc.1994—
*K952186HSW GMBH Hysteroscopes & Accessories
Summary page 1
…e and accessories Class: II 3. Predicate Device: Henke Sass Wolf Hysteroscopes, Hysteroscopic Resecto scopes and Accessories (K941541 I K952186 / K991563) Smith & Nephew Hysteroscope and Accessories (K013 870) Stryker Urology and Gynecology Hardware System…
Henke-Sass, Wolf GmbH1996—
*K991563Continuous Flow Hystero-Resectoscope, Knife Electrode, Spike Electrode, Vaporisation…
Summary page 1
…ssories Class: II 3. Predicate Device: Henke Sass Wolf Hysteroscopes, Hysteroscopic Resecto scopes and Accessories (K941541 I K952186 / K991563) Smith & Nephew Hysteroscope and Accessories (K013 870) Stryker Urology and Gynecology Hardware System (K0403 90…
Henke Sass Wolf of America, Inc.1999—
*K013870Smith & Nephew Operative Hysteroscope, Model 7209208; Smith & Nephew Continuous Flow…
Summary page 1
…Henke Sass Wolf Hysteroscopes, Hysteroscopic Resecto scopes and Accessories (K941541 I K952186 / K991563) Smith & Nephew Hysteroscope and Accessories (K013 870) Stryker Urology and Gynecology Hardware System (K0403 90) 4. Device Description: The MyoSURETm Rod Lens…
Smith & Nephew, Inc.2002—
*K040390Stryker Urology and Gynecology Hardware System
Summary page 1
…Accessories (K941541 I K952186 / K991563) Smith & Nephew Hysteroscope and Accessories (K013 870) Stryker Urology and Gynecology Hardware System (K0403 90) 4. Device Description: The MyoSURETm Rod Lens Hysteroscope is comprised of an oval 6.0 mm x 6.4mm OD x 18…
Stryker Endoscopy2004—
†K081070Interlace Medical Operative Hysteroscopy SystemInterlace Medical, Inc.2008—

Also cleared against K941541: 1 other device →

What descends from it? (4)

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

NumberDeviceApplicantDecidedDescendants
K122563Myosure XL Rod Lens Hysteroscope, Myosure XL Outlfow ChannelHologic, Inc.20122
K182006Omni Hysteroscope, Omni Hysteroscope Kits, Omni SheathsHologic, Inc.20181
K102686Myosure Rod Lens Scope SealsInterlace Medical, Inc.20100

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 14 years and passes through 3 companies; a new generation was cleared every 9.9 years on median.
  • None of the 8 ancestors has a recall.
  • Of its descendants, K122563 (Hologic, Inc., 2012) has gone furthest, with 2 descendants of its own.
  • 1 other device also cites its predicate K941541.

How does its category compare?

All HIH devices

HIH Hysteroscope (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 MyoSURETM Rod Lens Hysteroscope is used to provide viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures.

Indications for use as stated in the FDA summary.

Also cleared against K941541

1 other device cites the same predicate.

  • K201198S+N Laparoscopes, 4KO, Autoclavable, S+N Bariactric Laparoscopes, 4KO, AutoclavableSmith & Nephew · 2020

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
  • 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/K091465 · printed Nov 5, 2026

Cite this page

510(k) Report. “K091465: Myosure Rod Lens Hysteroscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K091465

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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