PrimeSight™ UNITY 9000 Video Processor, PrimeSight™ UNITY 9100 Video Processor

Esophagoscope (flexible Or Rigid)

Cogentix Medical, Inc.

The following data is part of a premarket notification filed by Cogentix Medical, Inc. with the FDA for Primesight™ Unity 9000 Video Processor, Primesight™ Unity 9100 Video Processor.

Pre-market Notification Details

• Device ID: K181292
• 510k Number: K181292
• Device Name: PrimeSight™ UNITY 9000 Video Processor, PrimeSight™ UNITY 9100 Video Processor
• Classification: Esophagoscope (flexible Or Rigid)
• Applicant: Cogentix Medical, Inc. 40 Ramland Road South Orangeburg, NY 10962
• Contact: Christa Blaisdell
• Correspondent: Christa Blaisdell; Cogentix Medical, Inc. 40 Ramland Road South Orangeburg, NY 10962
• Product Code: EOX
• Subsequent Product Code: EOB
• Subsequent Product Code: EOQ
• Subsequent Product Code: FAJ
• Subsequent Product Code: OCS
• CFR Regulation Number: 874.4710 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-05-16
• Decision Date: 2018-11-15
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00874485003227	K181292	000
00874485003210	K181292	000