Reshape Lifesciences

FDA Filings

This page includes the latest FDA filings for Reshape Lifesciences. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3013508647
• FEI Number: 3013508647
• Name: ReShape Lifesciences
• Owner & Operator: ReShape Lifesciences
• Contact Address: 1001 Calle Amanecer ; San Clemente CA 92673 US
• Official Correspondent:
  • Dov Gal
  • x-949-4814789-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 1001 Calle Amanecer ; San Clemente, CA 92673 US
• Establishment Type: Complaint File Establishment per 21 CFR 820.198

FDA Owner/Operator Registration

FDA Filings

Device Company	Device	Date
PMN K221898 ReShape Lifesciences	Gastrointestinal Boundary Identifier (GIBI HD)	2022-07-28
PMN K220455 ReShape Lifesciences	Lap-Band System Calibration Tube	2022-06-07
PMN K002838 | KNT ReShape Lifesciences	Gastric Balloon Suction Catheter	2019-02-08
PMN P000008 | LTI ReShape Lifesciences	LAP-BAND AP System Large with RapidPort EZ Access Port; LAP-BAND AP System Standard with RapidPort EZ Access Port; LAP-B	2019-01-30

Similar & Related FDA Registered Companies

• ReShape Lifesciences, Inc.
• ReShape Lifesciences, Inc.1001 Calle Amanecersan Clemente, CA 92673 PMA NumberP160001 Supplement NumberS047 Date Received01/19/2022 Decision Date07/18/2022 Product Code LTI  Advisory Committee Gastroenterology/Urology Supplement Typenormal 180 Day Track No User Fee Supplement Reason Labeling Change - Pas Expedited Review Granted? No