Reshape Lifesciences Inc

FDA Filings

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

USA

OTHER OTC Market

RSLS

DUNS 144998551

FDA Registration(s)

• Registration Number: 3005025697
• FEI Number: 3005025697
• Name: ReShape Lifesciences, LLC.
• Owner & Operator: ReShape Lifesciences, Inc.
• Contact Address: 2800 Patton Road Suite B; Saint Paul MN 55113 US
• Official Correspondent:
  • Dov Gal
  • x-949-4814789-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 2800 Patton Rd Suite B; Saint Paul, MN 55113 US
• Establishment Type: Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device Company	Device	Date
GUDID 00850007764470 ReShape Lifesciences Inc.	ReShape Calibration Tubes™ B-2017	2025-08-11
GUDID 00850007764586 Reshape Lifesciences Inc.	ReShape Lap-Band® 2.0, FLEX Tubing Kit D-3500	2024-01-30
GUDID 00850007764555 Reshape Lifesciences Inc.	ReShape Lap-Band® 2.0, FLEX & Access Port, Large D-3306	2024-01-30
GUDID 00850007764548 Reshape Lifesciences Inc.	ReShape Lap-Band® 2.0, FLEX & Access Port, Standard D-3304	2024-01-30
GUDID 00850007764517 Reshape Lifesciences Inc.	ReShape Lap-Band® 2.0 FLEX, Large D-3365	2024-01-30
GUDID 00850007764500 Reshape Lifesciences Inc.	ReShape Lap-Band® 2.0 FLEX, Standard D-3360	2024-01-30
GUDID 00850007764272 Reshape Lifesciences Inc.	ReShape Calibration Tubes B-2040	2023-03-24
GUDID 00850007764265 Reshape Lifesciences Inc.	ReShape Calibration Tubes B-2036	2023-03-24
GUDID 00850007764258 Reshape Lifesciences Inc.	ReShape Calibration Tubes B-2032	2023-03-24
GUDID 00850007764234 Reshape Lifesciences Inc.	GIBI HD B-2040	2022-08-15
GUDID 00850007764227 Reshape Lifesciences Inc.	GIBI HD B-2036	2022-08-15
GUDID 00850007764210 Reshape Lifesciences Inc.	GIBI HD B-2032	2022-08-15
GUDID 10850007764330 Reshape Lifesciences Inc.	LAP-BAND® System Access Port Needle, 20G x 89 mm (3.5 in.) B-20301-10	2021-04-09
GUDID 10850007764323 Reshape Lifesciences Inc.	LAP-BAND® System Access Port Needle, 20G x 51 mm (2 in.) B-20302-10	2021-04-09
GUDID 00850007764654 Reshape Lifesciences Inc.	LAP-BAND AP® System Large with RapidPort® EZ C-2365	2021-02-09
GUDID 00850007764609 Reshape Lifesciences Inc.	LAP-BAND AP® System Standard with RapidPort® EZ C-2360	2021-02-09
GUDID 00850007764067 Reshape Lifesciences Inc.	RapidPort® EZ Access Port Kit - 14cc C-2306	2021-02-09
GUDID 00850007764043 Reshape Lifesciences Inc.	RapidPort® EZ Access Port Kit - 10cc C-2304	2021-02-09
GUDID 00850007764906 Reshape Lifesciences Inc.	RapidPort® EZ Port Applier C-20390	2021-01-11
GUDID 00850007764173 Reshape Lifesciences Inc.	LAP-BAND® System Calibration Tube B-2017	2020-12-09
GUDID 00850007764203 Reshape Lifesciences Inc.	Gastric Balloon Suction Catheter B-2020	2020-11-09
PMA P000008S047 ReShape Lifesciences, Inc.	LAP-BAND System	2019-11-13
PMA P000008S045 ReShape Lifesciences, Inc.	LAP-BAND Adjustable Gastric Banding System	2019-05-02
PMA P130019S019 ReShape Lifesciences, Inc.	Maestro Rechargeable System	2019-02-15
PMA P130019S018 ReShape Lifesciences, Inc.	Maestro Rechargeable System	2019-01-25
PMA P130019S017 ReShape Lifesciences, Inc.	Maestro Rechargeable System	2019-01-25
PMA P000008S046 ReShape Lifesciences, Inc.	Lap-Band Adjustable Gastric Banding System	2019-01-18
PMA P000008S044 ReShape Lifesciences, Inc.	LAP-BAND Adjustable Gastric Banding System	2018-11-30
PMA P000008S043 ReShape Lifesciences, Inc.	LAP-BAND Adjustable Gastric Banding System	2018-07-20
PMA P130019S015 ReShape Lifesciences, Inc.	Maestro Rechargeable System	2018-01-24
PMA P000008S042 ReShape Lifesciences, Inc.	LAP-BAND Adjustable Gastric Banding System	2018-01-23
PMA P130019S016 ReShape Lifesciences, Inc.	Maestro Rechargeable System	2018-01-22
PMA P000008S041 ReShape Lifesciences, Inc.	LAP-BAND Adjustable Gastric Banding System	2018-01-18
PMA P000008S040 ReShape Lifesciences, Inc.	LAP-BAND Adjustable Gastric Banding System	2018-01-16
PMA P000008S039 ReShape Lifesciences, Inc.	Lap-Band Adjustable Gastric Banding System	2017-10-02
PMA P130019S014 ReShape Lifesciences, Inc.	Maestro Rechargeable System	2017-05-24
PMA P000008S038 ReShape Lifesciences, Inc.	LAP-BAND Adjustable Gastric Banding System	2017-03-23
PMA P130019S013 ReShape Lifesciences, Inc.	Maestro Rechargeable System	2017-03-22
PMA P130019S012 ReShape Lifesciences, Inc.	MAESTRO RECHARGEABLE SYSTEM	2016-12-22
PMA P130019S011 ReShape Lifesciences, Inc.	MAESTRO RECHARGEABLE SYSTEM	2016-11-21
PMA P130019S010 ReShape Lifesciences, Inc.	MAESTRO RECHARGEABLE SYSTEM	2016-09-20
PMA P130019S009 ReShape Lifesciences, Inc.	MAESTRO RECHARGEABLE SYSTEM	2016-06-27
PMA P130019S008 ReShape Lifesciences, Inc.	MAESTRO RECHARGEABLE SYSTEM	2016-06-03
PMA P000008S035 ReShape Lifesciences, Inc.	LAP-BAND ADJUSTABLE GASTIC BANDING SYSTEM	2016-05-23
PMA P000008S037 ReShape Lifesciences, Inc.	LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM	2016-03-28
PMA P000008S034 ReShape Lifesciences, Inc.	LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM	2016-03-03
PMA P130019S007 ReShape Lifesciences, Inc.	MAESTRO RECHARGEABLE SYSTEM	2016-02-12
PMA P000008S036 ReShape Lifesciences, Inc.	LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM	2016-02-08
PMA P130019S002 ReShape Lifesciences, Inc.	MAESTRO RECHARGEABLE SYSTEM	2015-07-24
PMA P130019S001 ReShape Lifesciences, Inc.	MAESTRO RECHARGEABLE SYSTEM	2015-06-02
PMA P000008S033 ReShape Lifesciences, Inc.	ADJUSTABLE GASTRIC BANDING SYSTEM	2015-05-27
PMA P130019S005 ReShape Lifesciences, Inc.	MAESTRO RECHARGEABLE SYSTEM	2015-04-24
PMA P130019S004 ReShape Lifesciences, Inc.	MAESTRO RECHARGEABLE SYSTEM	2015-04-22
PMA P130019S003 ReShape Lifesciences, Inc.	MAESTRO RECHARGEABLE SYSTEM	2015-04-22
PMA P130019S006 ReShape Lifesciences, Inc.	MAESTRO RECHARGEABLE SYSTEM	2015-04-17
PMN P130019 | PIM ReShape Lifesciences, LLC. [ReShape Lifesciences, Inc.]	vBloc	2015-01-26
PMN P130019 | PIM ReShape Lifesciences, LLC. [ReShape Lifesciences, Inc.]	vBloc Therapy	2015-01-26
PMN P130019 | PIM ReShape Lifesciences, LLC. [ReShape Lifesciences, Inc.]	vBloc System	2015-01-26
PMN P130019 | PIM ReShape Lifesciences, LLC. [ReShape Lifesciences, Inc.]	vBloc Rechargeable System	2015-01-26
PMN P130019 | PIM ReShape Lifesciences, LLC. [ReShape Lifesciences, Inc.]	vBloc Neurometabolic Therapy	2015-01-26
PMN P130019 | PIM ReShape Lifesciences, LLC. [ReShape Lifesciences, Inc.]	Model 2504 Maestro Clinician Programmer Kit	2015-01-26
PMN P130019 | PIM ReShape Lifesciences, LLC. [ReShape Lifesciences, Inc.]	Model 2502 Maestro Clinician Programmer	2015-01-26
PMN P130019 | PIM ReShape Lifesciences, LLC. [ReShape Lifesciences, Inc.]	Model 2404 Maestro Patient Kit	2015-01-26
PMN P130019 | PIM ReShape Lifesciences, LLC. [ReShape Lifesciences, Inc.]	Model 2403-60 Maestro Patient Transmit Coil	2015-01-26
PMN P130019 | PIM ReShape Lifesciences, LLC. [ReShape Lifesciences, Inc.]	Model 2403-300 Maestro Clinician Transmit Coil	2015-01-26
PMN P130019 | PIM ReShape Lifesciences, LLC. [ReShape Lifesciences, Inc.]	Model 2402 Maestro Mobile Charger	2015-01-26
PMN P130019 | PIM ReShape Lifesciences, LLC. [ReShape Lifesciences, Inc.]	Model 2200P-47E Maestro Posterior Lead	2015-01-26
PMN P130019 | PIM ReShape Lifesciences, LLC. [ReShape Lifesciences, Inc.]	Model 2200A-47E Maestro Anterior Lead	2015-01-26
PMN P130019 | PIM ReShape Lifesciences, LLC. [ReShape Lifesciences, Inc.]	Model 2004 Maestro Implant Kit	2015-01-26
PMN P130019 | PIM ReShape Lifesciences, LLC. [ReShape Lifesciences, Inc.]	Model 2002 Maestro Rechargeable Neuroregulator	2015-01-26
PMN P130019 | PIM ReShape Lifesciences, LLC. [ReShape Lifesciences, Inc.]	Model 1680 Torque Wrench	2015-01-26
PMN P130019 | PIM ReShape Lifesciences, LLC. [ReShape Lifesciences, Inc.]	Model 1660 Maestro Patient Transmit Coil Belt	2015-01-26
PMN P130019 | PIM ReShape Lifesciences, LLC. [ReShape Lifesciences, Inc.]	Model 1620 AC Recharger	2015-01-26
PMN P130019 | PIM ReShape Lifesciences, LLC. [ReShape Lifesciences, Inc.]	Model 1600 Programmer Cable	2015-01-26
PMN P130019 | PIM ReShape Lifesciences, LLC. [ReShape Lifesciences, Inc.]	Maestro	2015-01-26
PMN P130019 | PIM ReShape Lifesciences, LLC. [ReShape Lifesciences, Inc.]	Maestro System	2015-01-26
PMN P130019 | PIM ReShape Lifesciences, LLC. [ReShape Lifesciences, Inc.]	Maestro Rechargeable System	2015-01-26
PMN P130019 | PIM ReShape Lifesciences, LLC. [ReShape Lifesciences, Inc.]	Maestro Obesity Management System	2015-01-26
PMN P130019 | PIM ReShape Lifesciences, LLC. [ReShape Lifesciences, Inc.]	EnteroMedics	2015-01-26
PMA P130019 ReShape Lifesciences, Inc.	MAESTRO RECHARGEABLE SYSTEM	2015-01-14
PMA P000008S032 ReShape Lifesciences, Inc.	LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM	2014-11-05
PMA P000008S028 ReShape Lifesciences, Inc.	LAP-BAND ADJUSTABLE GASTRIC BANDING (LAGB) SYSTEM	2014-10-07
PMA P000008S031 ReShape Lifesciences, Inc.	LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM	2014-09-24
PMA P000008S027 ReShape Lifesciences, Inc.	LAP-BAND ADJUSTABLE GASTRIC BAND	2013-08-29
PMA P000008S030 ReShape Lifesciences, Inc.	LAP-BAND ADJUSTABLE GASTRIC BANDING (LAGB) SYSTEM	2013-03-27
PMA P000008S029 ReShape Lifesciences, Inc.	LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM	2012-11-09
PMA P000008S026 ReShape Lifesciences, Inc.	LAP-BAND ADJUSTABLE GASTRIC BANDING (LAGB) SYSTEM	2011-12-09
PMA P000008S022 ReShape Lifesciences, Inc.	LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM	2011-11-18
PMA P000008S019 ReShape Lifesciences, Inc.	LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM	2011-09-16
PMA P000008S023 ReShape Lifesciences, Inc.	LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM	2011-08-15
PMA P000008S024 ReShape Lifesciences, Inc.	LAP-BAND ADJUSTABLE GASTRIC BANDING (LAGB) SYSTEM	2011-07-29
PMA P000008S017 ReShape Lifesciences, Inc.	LAP-BAND	2011-02-16
PMA P000008S021 ReShape Lifesciences, Inc.	LAP-BAND ADJUSTABLE GASTRIC BANDING (LAGB) SYSTEM	2010-12-14
PMA P000008S020 ReShape Lifesciences, Inc.	LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM	2010-10-08
PMA P000008S018 ReShape Lifesciences, Inc.	LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM	2010-06-18
PMA P000008S014 ReShape Lifesciences, Inc.	LAP-BAND ADJUSTABLE GASTRIC BANDING (LAGB) SYSTEM	2009-01-16
PMA P000008S013 ReShape Lifesciences, Inc.	LAP-BAND ADJUSTABLE GASTRIC BANDING (LAGB) SYSTEM	2008-11-25
PMA P000008S012 ReShape Lifesciences, Inc.	LAP-BAND ADJUSTABLE GASTRIC BANDING (LAGB) SYSTEM	2008-08-26
PMA P000008S010 ReShape Lifesciences, Inc.	LAP BAND ADJUSTABLE GASTRIC BANDING (LAGB) SYSTEM	2007-08-22
PMA P000008S009 ReShape Lifesciences, Inc.	LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM	2006-04-24
PMA P000008S008 ReShape Lifesciences, Inc.	LAP-BAND ADJUSTABLE GASTRIC BANDING (LAGB) SYSTEM	2006-02-02
PMA P000008S006 ReShape Lifesciences, Inc.	BIOENTERICS LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM	2003-12-05
PMA P000008S005 ReShape Lifesciences, Inc.	BIOENTERICS LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM	2003-01-08
PMA P000008S004 ReShape Lifesciences, Inc.	BIOENTERICS LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM	2002-09-10
PMA P000008S001 ReShape Lifesciences, Inc.	BIOENTERICS LAP-BAND	2002-08-26
PMA P000008S002 ReShape Lifesciences, Inc.	BIOENTERICS LAP-BAND ADJUSTABLE GASTRIC BANDING (LAGB) SYSTEM	2002-08-01
PMA P000008S003 ReShape Lifesciences, Inc.	BIOENTERICS LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM	2002-05-24
PMA P000008 ReShape Lifesciences, Inc.	LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM	2001-06-05

Similar & Related FDA Registered Companies

• 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

Related Finance Registrations

NCAGE Code	61TK5	RESHAPE LIFESCIENCES INC.
CAGE Code	61TK5	RESHAPE LIFESCIENCES INC.
S.A.M. Registration	61TK5 [144998551]	RESHAPE LIFESCIENCES INC.
DUNS	144998551	ReShape Lifesciences Inc.
SEC	0001371217	ReShape Lifesciences Inc. of DELAWARE