AmplifEYE

Endoscopic Access Overtube, Gastroenterology-urology

MEDIVATORS, INC.

The following data is part of a premarket notification filed by Medivators, Inc. with the FDA for Amplifeye.

Pre-market Notification Details

• Device ID: K160846
• 510k Number: K160846
• Device Name: AmplifEYE
• Classification: Endoscopic Access Overtube, Gastroenterology-urology
• Applicant: MEDIVATORS, INC. 3150 POLLOK DR. Conroe, TX 77303
• Contact: Jeff Kasoff
• Correspondent: Kristin Bergeson Padilla; MEDIVATORS INC. 14605 28TH AVE N Minneapolis, MN 55447
• Product Code: FED
• CFR Regulation Number: 876.1500 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-03-28
• Decision Date: 2016-07-14
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
20677964074206	K160846	000
20677964074190	K160846	000