Cleared Traditional

K180752 - Veloxion System, Veloxion Controller Kit, Veloxion Resecting Device Kit, Veloxion Fluid Control Set, Veloxion Saline Pole

K180752 is an FDA 510(k) clearance for Veloxion System, manufactured by Corinth Medtech, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HIH cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K180752 · Corinth Medtech, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2018
Decision
125d
Days
Class 2
Risk

K180752 is an FDA 510(k) clearance for the Veloxion System, Veloxion Controller Kit, Veloxion Resecting Device Kit, Velo.... Classified as Hysteroscope (and Accessories) (product code HIH), Class II - Special Controls.

Submitted by Corinth Medtech, Inc. (Cupertino, US). The FDA issued a Cleared decision on July 25, 2018 after a review of 125 days - within the typical 510(k) review window.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1690 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Corinth Medtech, Inc. devices

FDA 510(k) Submission Details - K180752

510(k) Number K180752 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 2018
Decision Date July 25, 2018
Days to Decision 125 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 161d · This submission: 125d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HIH Device Classification - Class 2, Special Controls

Product Code HIH Hysteroscope (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1690
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - HIH Hysteroscope (and Accessories)

All 158
Devices cleared under the same product code (HIH) and FDA review panel - the closest regulatory comparables to K180752.
Omni Hysteroscope, Omni Hysteroscope Kits, Omni Sheaths
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TruClear Elite Hysteroscope
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MyoSure XL Tissue Removal Device for Fluent
K181974 · Hologic, Inc. · Aug 2018
HSW Resection Instruments
K173070 · Henke-Sass, Wolf GmbH · Jun 2018
MyoSure MANUAL Tissue Removal Device
K173901 · Hologic, Inc. · May 2018
GDT-1000 System
K180096 · Acuvu, Inc. · Apr 2018