510(k) Report

510(k) · Cleared

Cleared

Veloxion System, Veloxion Controller Kit, Veloxion Resecting Device Kit, Veloxion Fluid Control Set, Veloxion Saline Pole

K180752510(k) TraditionalCleared Jul 25, 2018125-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

Corinth Medtech, Inc. · HIH Hysteroscope (And Accessories)

Cleared on Jul 25, 2018 as substantially equivalent to K042523 (Richard Wolf Medical Instruments Corp., 2005) and 3 other predicates after a 125-day review. Its family tree reaches back 3 generations to 1994. 2 later devices descend from it.

Decided
Jul 25, 2018
Review
125 days
Class
Class II
Product code
HIH
Recalls
None
Predicates
4

Its longest line of descent runs back 3 generations to K933002 (1994). 8 ancestors in all. 2 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2005: 1 other ancestor2003: 1 other ancestor1996: 1 other ancestor1995: 2 other ancestors2019: 2 descendants clearedK933002 · Erbotom Icc 350 · Erbe USA, Inc. · 1994K023886 · Erbe Vio Esu with Accessories, Model Vio 300 D · Erbe USA, Inc. · 2002K162979 · Veloxion System · Corinth Medtech, Inc. · 20171990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 3 other ancestors 1 generation forward: 1 descendant2 generations forward: 1 descendant K162979 · Veloxion System · Corinth Medtech, Inc. · 2017K023886 · Erbe Vio Esu with Accessories, Model Vio 300 D · Erbe USA, Inc. · 2002K933002 · Erbotom Icc 350 · Erbe USA, Inc. · 19940
  1. Root · 3 generations backK933002 Erbotom Icc 350Erbe USA, Inc. · 1994
  2. 2 generations backK023886 Erbe Vio Esu with Accessories, Model Vio 300 DErbe USA, Inc. · 2002
  3. 1 generation backK162979 Veloxion SystemCorinth Medtech, Inc. · 2017
  4. This deviceK180752 Veloxion System, Veloxion Controller Kit, Veloxion Resecting Device…Corinth Medtech, Inc. · 2018
  5. Descendant · cites it directly · 1 of its ownK190113 Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion…Corinth Medtech, Inc. · 2019
  6. Descendant · 2 generations on · 0 of its ownK191335 Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion…Corinth Medtech, Inc. · 2019

Most influential descendants

Showing 2 of 2 · See all
  • K190113Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion…Corinth Medtech, Inc. · 2019 · cites it directly1descendant
  • K191335Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion…Corinth Medtech, Inc. · 2019 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K933002Erbotom Icc 350Erbe USA, Inc.1994—
−2K023886Erbe Vio Esu with Accessories, Model Vio 300 DErbe USA, Inc.2002—
−1K162979Veloxion SystemCorinth Medtech, Inc.2017—
0 (this device)K180752Veloxion System, Veloxion Controller Kit, Veloxion Resecting Device Kit…Corinth Medtech, Inc.2018—
+1K190113Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope…Corinth Medtech, Inc.2019—
+2K191335Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope…Corinth Medtech, Inc.2019—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199520
199610
200310
200510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201920
FIG. 1 — Lineage of K180752, 1994–2019Source: 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? (4)

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
*K042523Resection Pump, Resectoscope for Chip Aspiration, Endoscope 25/ 3.3 MM, Accessories
Summary page 4
…lence is claimed: Primary Predicate: Richard Wolf Medical Instruments Corporation: • Resection Pump and Resectoscope for Chip Aspiration (K042523) • Hystero Pump II 2222 and Fluid Monitoring 2223 (K022449) Predicate: ERBE, USA Inc., E…
Richard Wolf Medical Instruments Corp.2005—
*K022449Hystereoscopy Pump HM4
Summary page 4
…on: • Resection Pump and Resectoscope for Chip Aspiration (K042523) • Hystero Pump II 2222 and Fluid Monitoring 2223 (K022449) Predicate: ERBE, USA Inc., ERBE ESU Model VIO 300D with Accessories (K023886) Predicate: Veloxion…
W.O.M. World of Medicine AG2003—
*K023886Erbe Vio Esu with Accessories, Model Vio 300 D
Summary page 4
…• Hystero Pump II 2222 and Fluid Monitoring 2223 (K022449) Predicate: ERBE, USA Inc., ERBE ESU Model VIO 300D with Accessories (K023886) Predicate: Veloxion System (cleared per K162979) None of the predicates have been subject of a design relat…
Erbe USA, Inc.2002—
*K162979Veloxion System
Summary page 4
…toring 2223 (K022449) Predicate: ERBE, USA Inc., ERBE ESU Model VIO 300D with Accessories (K023886) Predicate: Veloxion System (cleared per K162979) None of the predicates have been subject of a design related recall. IV. Device Description The Veloxion System cons…
Corinth Medtech, Inc.2017—

Also cleared against K042523: 3 other devices →

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K190113Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion…Corinth Medtech, Inc.20191

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 24 years and passes through 2 companies; a new generation was cleared every 8.8 years on median.
  • None of the 8 ancestors has a recall.
  • Of its descendants, K190113 (Corinth Medtech, Inc., 2019) has gone furthest, with 1 descendant of its own.
  • 3 other devices also cite its predicate K042523.

How does its category compare?

All HIH devices

HIH Hysteroscope (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 Veloxion System is intended for intrauterine use by trained gynecologists for endoscopically controlled tissue chip resection and coagulation, and removal of intrauterine polyps and myomas via suction channel under continuous flow conditions following resection using a bipolar resecting device. It is also intended to distend the uterus by filling with saline to facilitate viewing with a hysteroscope and to monitor the volume differential between fluid flowing into and out of the uterus.

Indications for use as stated in the FDA summary.

Also cleared against K042523

3 other devices cite the same predicate.

  • K191341Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit…Corinth Medtech, Inc. · 2019
  • K162979Veloxion SystemCorinth Medtech, Inc. · 2017
  • K062720S-Line Bipolar Resectoscopes and Bipolar ElectrodesRichard Wolf Medical Instruments Corp. · 20072 recalls

More from Corinth Medtech, Inc.

7 FDA decisions under this applicant name. See the company

  • K230205Veloxion SystemCorinth Medtech, Inc. · 2023
  • K191341Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit…Corinth Medtech, Inc. · 2019
  • K191335Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit…Corinth Medtech, Inc. · 2019
  • K190113Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit…Corinth Medtech, Inc. · 2019
  • K190099Veloxion Controller Kit, Veloxion Fluid Control Kit, Veloxion Resectoscope, Veloxion Video Control Unit…Corinth Medtech, Inc. · 2019

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/K180752 · printed Nov 3, 2026

Cite this page

510(k) Report. “K180752: Veloxion System, Veloxion Controller Kit, Veloxion Resecting Device Kit, Veloxion Fluid Control Set, Veloxion Saline Pole.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K180752

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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