ENDOSIZE

System, Image Processing, Radiological

THERENVA SAS

The following data is part of a premarket notification filed by Therenva Sas with the FDA for Endosize.

Pre-market Notification Details

• Device ID: K141475
• 510k Number: K141475
• Device Name: ENDOSIZE
• Classification: System, Image Processing, Radiological
• Applicant: THERENVA SAS 2 RUE HENRI LE GUILLOUX Rennes, FR 35000
• Contact: Cemil Goksu
• Correspondent: Mark Job; REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114
• Product Code: LLZ
• CFR Regulation Number: 892.2050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: Yes
• Combination Product: No
• Date Received: 2014-06-04
• Decision Date: 2014-07-31
• Summary: summary