510(k) Report

510(k) · Cleared

Cleared

MVM 7.5 French Flexible Hysteroscope

K990411510(k) TraditionalCleared May 11, 199990-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

Karl Storz Endoscopy · HIH Hysteroscope (And Accessories)

Cleared on May 11, 1999 after a 90-day review. The FDA summary names no predicate by number. 24 later devices descend from it.

Decided
May 11, 1999
Review
90 days
Class
Class II
Product code
HIH
Recalls
None
Predicates
0

24 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2009: 1 descendant cleared1999: 1 descendant cleared2018: 1 descendant cleared2010: 1 descendant cleared2013: 1 descendant cleared2017: 1 descendant cleared2014: 1 descendant cleared2020: 2 descendants cleared2019: 5 descendants cleared2021: 2 descendants cleared2015: 1 descendant cleared2016: 1 descendant cleared2024: 3 descendants cleared2025: 1 descendant cleared2026: 2 descendants cleared1995200020052010201520202025
  1. This deviceK990411 MVM 7.5 French Flexible HysteroscopeKarl Storz Endoscopy · 1999
  2. Descendant · cites it directly · 22 of its ownK092278 Gyrus Acmi Invisio Digital Hysteroscope, Model Idh-4Gyrus Acmi, Inc. · 2009
  3. Descendant · 2 generations on · 20 of its ownK123151 Endosee Model 8000 U-ScopeEndosee Corp · 2013
  4. Descendant · 3 generations on · 19 of its ownK132384 U-Scope 8000 System with HSC+Emb CannulaEndosec Corporation · 2014
  5. Descendant · 3 generations on · 5 of its ownK170660 Endosee Hysteroscope with Disposable Diagnostic (Dx) CannulaCooperSurgical, Inc. · 2017
  6. Descendant · 4 generations on · 4 of its ownK202445 Hystero-V HysteroscopeHysterovue, Inc. · 2021

Showing 5 of 24 descendants. See all descendants

Descendants cleared per year

1999: 12009: 12010: 12013: 12014: 12015: 12016: 12017: 12018: 12019: 52020: 22021: 22024: 32025: 12026: 2
1999high 5 (2019) · low 0 (2000)2026

Most influential descendants

Showing 5 of 24 · See all
  • K092278Gyrus Acmi Invisio Digital Hysteroscope, Model Idh-4Gyrus Acmi, Inc. · 2009 · cites it directly22descendants
  • K123151Endosee Model 8000 U-ScopeEndosee Corp · 2013 · 2 generations on20descendants
  • K132384U-Scope 8000 System with HSC+Emb CannulaEndosec Corporation · 2014 · 3 generations on19descendants
  • K170660Endosee Hysteroscope with Disposable Diagnostic (Dx) CannulaCooperSurgical, Inc. · 2017 · 3 generations on5descendants
  • K202445Hystero-V HysteroscopeHysterovue, Inc. · 2021 · 4 generations on4descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K990411MVM 7.5 French Flexible HysteroscopeKarl Storz Endoscopy1999—
+1K092278Gyrus Acmi Invisio Digital Hysteroscope, Model Idh-4Gyrus Acmi, Inc.2009—
+2K123151Endosee Model 8000 U-ScopeEndosee Corp2013—
+3K132384U-Scope 8000 System with HSC+Emb CannulaEndosec Corporation2014—
+3K170660Endosee Hysteroscope with Disposable Diagnostic (Dx) CannulaCooperSurgical, Inc.2017—
+4K202445Hystero-V HysteroscopeHysterovue, Inc.2021—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
200910
201010
201310
201410
201510
201610
201710
201810
201950
202020
202120
202430
202510
202620
FIG. 1 — Lineage of K990411, 1999–2026Source: 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?

The FDA summary names no predicate by number.

What descends from it? (24)

See all 24

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

NumberDeviceApplicantDecidedDescendants
K092278Gyrus Acmi Invisio Digital Hysteroscope, Model Idh-4Gyrus Acmi, Inc.200922
K993445Omnisonic Endoscopic DeflectorOmnisonics Medical Technologies19990

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?

  • Of its descendants, K092278 (Gyrus Acmi, Inc., 2009) has gone furthest, with 22 descendants of its own.

How does its category compare?

All HIH devices

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

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?

This instrument is indicated for examination of the cervix and uterus and, using additional accessories, to perform various diagnostic and therapeutic procedures including;

Diagnostic Hysteroscopy

abnormal uterine bleeding

infertility and pregnancy wastage

evaluvation of abnormal hysterosalpingogram

intrauterine foreign body

amenorrhea

pelvic pain

evaluation of abnormalities of the endometrium

monitoring IUD status

Operative Hysteroscopy

directed biopsy

removal of submucous fibroids and large polps

submucous myomectomy

transection of intrauterine adhesions

transection of intrauterine septa

endometrial ablation

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Karl Storz Endoscopy

35 FDA decisions under this applicant name. See the company

  • K043375Fisch Titanium Middle Ear ProsthesesKarl Storz Endoscopy · 2005
  • K030848Perforated Bioabsorbable Interference Screw MegafixKarl Storz Endoscopy · 2003
  • K030009Ksea Powershaver System S2Karl Storz Endoscopy · 20031 recall
  • K023924Autocon II 200 Electrosurgical GeneratorKarl Storz Endoscopy · 2003
  • K023187Ksea SpinoscopeKarl Storz Endoscopy · 2002

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/K990411 · printed Nov 4, 2026

Cite this page

510(k) Report. “K990411: MVM 7.5 French Flexible Hysteroscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K990411

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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