DiLumen Endolumenal Interventional Platform

Colonoscope And Accessories, Flexible/rigid

Lumendi, LLC

The following data is part of a premarket notification filed by Lumendi, Llc with the FDA for Dilumen Endolumenal Interventional Platform.

Pre-market Notification Details

• Device ID: K162428
• 510k Number: K162428
• Device Name: DiLumen Endolumenal Interventional Platform
• Classification: Colonoscope And Accessories, Flexible/rigid
• Applicant: Lumendi, LLC 253 Post Road West Westport, CT 06880
• Contact: Dennis Daniels
• Correspondent: John J. Smith; Hogan Lovells U.S. LLP 555 13th Street NW Washington, DC 20004
• Product Code: FDF
• CFR Regulation Number: 876.1500 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-08-30
• Decision Date: 2016-12-06
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00865309000201	K162428	000