Rescuenet

Snare, Flexible

ENDOCHOICE, INC.

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

Pre-market Notification Details

• Device ID: K152580
• 510k Number: K152580
• Device Name: Rescuenet
• Classification: Snare, Flexible
• Applicant: ENDOCHOICE, INC. 11810 WILLS RD. Alpharetta, GA 30009
• Contact: Daniel Hoefer
• Correspondent: Daniel Hoefer; ENDOCHOICE, INC. 11810 WILLS RD. Alpharetta, GA 30009
• Product Code: FDI
• CFR Regulation Number: 876.4300 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-09-10
• Decision Date: 2015-11-03
• Summary: summary