Veloxion System

Resectoscope

Corinth MedTech, Inc.

The following data is part of a premarket notification filed by Corinth Medtech, Inc. with the FDA for Veloxion System.

Pre-market Notification Details

• Device ID: K162979
• 510k Number: K162979
• Device Name: Veloxion System
• Classification: Resectoscope
• Applicant: Corinth MedTech, Inc. 1601 S. De Anza Blvd. Suite 221 Cupertino, CA 95014
• Contact: Sandeep Saboo
• Correspondent: Sandeep Saboo; Corinth MedTech, Inc. 1601 S. De Anza Blvd. Suite 221 Cupertino, CA 95014
• Product Code: FJL
• Subsequent Product Code: GEI
• Subsequent Product Code: KQT
• CFR Regulation Number: 876.1500 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-10-26
• Decision Date: 2017-03-24
• Summary: summary