Cleared Traditional

K190113 - Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags

K190113 is an FDA 510(k) clearance for Veloxion Controller Kit, 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 90-day FDA review.

K190113 · Corinth Medtech, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2019
Decision
90d
Days
Class 2
Risk

K190113 is an FDA 510(k) clearance for the Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, V.... 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 April 24, 2019 after a review of 90 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 - K190113

510(k) Number K190113 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 2019
Decision Date April 24, 2019
Days to Decision 90 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
71d faster than avg
Panel avg: 161d · This submission: 90d
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 K190113.
Aveta System
K190372 · Meditrina, Inc. · May 2019
Endosee System
K190639 · CooperSurgical, Inc. · May 2019
Hysteroscope System
K181545 · Shanghai AnQing Medical Instrument Co., Ltd. · May 2019
Endosee System
K183020 · CooperSurgical, Inc. · Jan 2019
Polygon Resection Device
K182675 · Polygon Medical, Inc. · Jan 2019
Omni Hysteroscope, Omni Hysteroscope Kits, Omni Sheaths
K182006 · Hologic, Inc. · Dec 2018