ReShape Lifesciences, LLC.

FDA Registration(s)#

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

• reshapelifesci.com

Registered Device Listings#

Product Codes Associated With Registrations#

PMA#

• Obalon Balloon System

  2022-07-18

  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 ...

• LAP-BAND System

  2019-11-13

  ReShape Lifesciences, Inc.

• LAP-BAND Adjustable Gastric Banding System

  2019-05-02

  ReShape Lifesciences, Inc.

• Maestro Rechargeable System

  2019-02-15

  ReShape Lifesciences, Inc.

• Maestro Rechargeable System

  2019-01-25

  ReShape Lifesciences, Inc.

• Maestro Rechargeable System

  2019-01-25

  ReShape Lifesciences, Inc.

• Lap-Band Adjustable Gastric Banding System

  2019-01-18

  ReShape Lifesciences, Inc.

• LAP-BAND Adjustable Gastric Banding System

  2018-11-30

  ReShape Lifesciences, Inc.

• LAP-BAND Adjustable Gastric Banding System

  2018-07-20

  ReShape Lifesciences, Inc.

• Maestro Rechargeable System

  2018-01-24

  ReShape Lifesciences, Inc.

• LAP-BAND Adjustable Gastric Banding System

  2018-01-23

  ReShape Lifesciences, Inc.

• Maestro Rechargeable System

  2018-01-22

  ReShape Lifesciences, Inc.

• LAP-BAND Adjustable Gastric Banding System

  2018-01-18

  ReShape Lifesciences, Inc.

• LAP-BAND Adjustable Gastric Banding System

  2018-01-16

  ReShape Lifesciences, Inc.

• Lap-Band Adjustable Gastric Banding System

  2017-10-02

  ReShape Lifesciences, Inc.

• Maestro Rechargeable System

  2017-05-24

  ReShape Lifesciences, Inc.

• LAP-BAND Adjustable Gastric Banding System

  2017-03-23

  ReShape Lifesciences, Inc.

• Maestro Rechargeable System

  2017-03-22

  ReShape Lifesciences, Inc.

• MAESTRO RECHARGEABLE SYSTEM

  2016-12-22

  ReShape Lifesciences, Inc.

• MAESTRO RECHARGEABLE SYSTEM

  2016-11-21

  ReShape Lifesciences, Inc.

• MAESTRO RECHARGEABLE SYSTEM

  2016-09-20

  ReShape Lifesciences, Inc.

• MAESTRO RECHARGEABLE SYSTEM

  2016-06-27

  ReShape Lifesciences, Inc.

• MAESTRO RECHARGEABLE SYSTEM

  2016-06-03

  ReShape Lifesciences, Inc.

• LAP-BAND ADJUSTABLE GASTIC BANDING SYSTEM

  2016-05-23

  ReShape Lifesciences, Inc.

• LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM

  2016-03-28

  ReShape Lifesciences, Inc.

• LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM

  2016-03-03

  ReShape Lifesciences, Inc.

• MAESTRO RECHARGEABLE SYSTEM

  2016-02-12

  ReShape Lifesciences, Inc.

• LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM

  2016-02-08

  ReShape Lifesciences, Inc.

• MAESTRO RECHARGEABLE SYSTEM

  2015-07-24

  ReShape Lifesciences, Inc.

• MAESTRO RECHARGEABLE SYSTEM

  2015-06-02

  ReShape Lifesciences, Inc.

• ADJUSTABLE GASTRIC BANDING SYSTEM

  2015-05-27

  ReShape Lifesciences, Inc.

• MAESTRO RECHARGEABLE SYSTEM

  2015-04-24

  ReShape Lifesciences, Inc.

• MAESTRO RECHARGEABLE SYSTEM

  2015-04-22

  ReShape Lifesciences, Inc.

• MAESTRO RECHARGEABLE SYSTEM

  2015-04-22

  ReShape Lifesciences, Inc.

• MAESTRO RECHARGEABLE SYSTEM

  2015-04-17

  ReShape Lifesciences, Inc.

• MAESTRO RECHARGEABLE SYSTEM

  2015-01-14

  ReShape Lifesciences, Inc.

• LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM

  2014-11-05

  ReShape Lifesciences, Inc.

• LAP-BAND ADJUSTABLE GASTRIC BANDING (LAGB) SYSTEM

  2014-10-07

  ReShape Lifesciences, Inc.

• LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM

  2014-09-24

  ReShape Lifesciences, Inc.

• LAP-BAND ADJUSTABLE GASTRIC BAND

  2013-08-29

  ReShape Lifesciences, Inc.

64 records. Showing 1-40. Next

PMN#

• ReShape Calibration Tubes (B-2032, B-2036, B-2040); ReShape Calibration Tubes (B-2017); Gastric Balloon Suction Catheter (B-2020)

  2024-05-16

  Reshape Lifesciences

• ReShape Calibration Tubes

  2023-02-15

  Reshape Lifesciences

• Gastrointestinal Boundary Identifier (GIBI HD)

  2022-07-28

  ReShape Lifesciences

• Lap-Band System Calibration Tube

  2022-06-07

  ReShape Lifesciences

GUDID#

• LAP-BAND® System Calibration Tube - B-2017

  ReShape Lifesciences Inc.

  2020-12-01

• Model 2504 Maestro Clinician Programmer Kit - The Model 2504 Clinician Programmer Kit consists of a Model 2502 Clinician Programmer, a Model 2402 Mobile Charger, a Model 2403-300 Clinician Transmit Coil, a Model 1620 AC Recharger, and a Model 1600 Programmer Cable that are packaged together.

  Reshape Lifesciences Inc.

  2015-04-17

• Model 2502 Maestro Clinician Programmer - The Model 2502 Clinician Programmer (CP) is a non-sterile external component that consists of a commercially available laptop computer configured with customized software. The CP connects to the Mobile Charger with a custom Programmer Cable. The CP enables the clinician to enter and modify therapy parameters and therapy schedule in the Rechargeable Neuroregulator. The graphical user interface of the CP allows the clinician to monitor system performance and patient compliance. The CP also provides access to the Instructions for Use manuals.

  Reshape Lifesciences Inc.

  2015-04-17

• Model 2404 Maestro Patient Kit - The Model 2404 Patient Kit consists of a Model 2402 Mobile Charger, a Model 2403-60 Patient Transmit Coil, a Model 1620 AC Recharger, and a Model 1660 Patient Transmit Coil Belt that are packaged together.

  Reshape Lifesciences Inc.

  2015-04-17

• Model 2403-60 Maestro Patient Transmit Coil - The Model 2403-60 Transmit Coil is a non-sterile external component for use by the patient. The Transmit Coil is placed over the Rechargeable Neuroregulator (RNR) and attached to the Mobile Charger to provide a radio frequency link with the RNR for charging and communication.

  Reshape Lifesciences Inc.

  2015-04-17

• Model 2403-300 Maestro Clinician Transmit Coil - The Model 2403-300 Transmit Coil is a non-sterile external component that is placed within a standard sterile sleeve for use by a clinician in the operating room. The Transmit Coil is placed over the Rechargeable Neuroregulator (RNR) and attached to the Mobile Charger to provide a radio frequency link with the RNR for charging and communication.

  Reshape Lifesciences Inc.

  2015-04-17

• Model 2402 Maestro Mobile Charger - The Model 2402 Mobile Charger (MC) is a non-sterile external component that is powered by a rechargeable, lithium-ion battery. The MC charges the Rechargeable Neuroregulator (RNR) when connected to a Transmit Coil positioned over the RNR. The MC also provides communication between the Clinician Programmer and RNR to allow up and down loading of data, display battery charge levels, indicate proper positioning of the Transmit Coil, alert patient to fault conditions, and allow for inactivation of therapy and turning off the RNR if needed.

  Reshape Lifesciences Inc.

  2015-04-17

• Model 2200P-47E Maestro Posterior Lead - The Model 2200P-47E Posterior Lead is provided sterile for implantation. It is a flexible lead that contains bipolar platinum/iridium tip and ring electrodes with an insulated lead body. Electrical current is delivered to the tip electrode which is implanted to be in contact with the posterior trunk of the vagus nerve to block nerve signals. The ring electrode is placed in contact with the stomach to measure lead impedance. Sutures are used to anchor and stabilize the lead placement. The lead is connected to the implanted Rechargeable Neuroregulator. The Posterior Lead contains a white stripe along the lead body, a white suture tab, and a white coating on its' conductor cables to distinguish it from the Anterior Lead.

  Reshape Lifesciences Inc.

  2015-04-17

• Model 2200A-47E Maestro Anterior Lead - The Model 2200A-47E Anterior Lead is provided sterile for implantation. It is a flexible lead that contains bipolar platinum/iridium tip and ring electrodes with an insulated lead body. Electrical current is delivered to the tip electrode which is implanted to be in contact with the anterior trunk of the vagus nerve to block nerve signals. The ring electrode is placed in contact with the stomach to measure lead impedance. Sutures are used to anchor and stabilize the lead placement. The lead is connected to the implanted Rechargeable Neuroregulator.

  Reshape Lifesciences Inc.

  2015-04-17

• Model 2004 Maestro Implant Kit - The Model 2004 Implant Kit consists of a Model 2002 Rechargeable Neuroregulator (including Model 1680 Torque Wrench), a Model 2200P-47E Maestro Posterior Lead, and a Model 2200A-47E Anterior Lead packaged together.

  Reshape Lifesciences Inc.

  2015-04-17

• Model 2002 Maestro Rechargeable Neuroregulator - The Model 2002 Rechargeable Neuroregulator (RNR) is provided sterile for implantation and has a hermetic case enclosure with an integrated coil that acts as an antenna for telemetry and recharging. The RNR is surgically implanted to deliver electrical current to the implanted leads. It contains a rechargeable battery which is charged transcutaneously using a Transmit Coil.

  Reshape Lifesciences Inc.

  2015-04-17

• Model 1680 Torque Wrench - The Model 1680 Torque Wrench is a sterile standard surgical wrench provided for use during the implant procedure to tighten the set screws that secure the leads to the Rechargeable Neuroregulator.

  Reshape Lifesciences Inc.

  2015-04-17

• Model 1660 Maestro Patient Transmit Coil Belt - The Model 1660 Patient Transmit Coil Belt is a non-sterile, optional external accessory that may be used to assist in holding the Patient Transmit Coil over the location of the implanted Rechargeable Neuroregulator during charging.

  Reshape Lifesciences Inc.

  2015-04-17

• Model 1620 AC Recharger - The Model 1620 AC Recharger is a non-sterile external power supply that connects to a power outlet for use in charging the battery within the Mobile Charger.

  Reshape Lifesciences Inc.

  2015-04-17

• Model 1600 Maestro Programmer Cable - The Model 1600 Programmer Cable is a non-sterile external component that is used to provide connectivity between the Model 2502 Clinician Programmer and the Model 2402 Mobile Charger.

  Reshape Lifesciences Inc.

  2015-04-17

• GIBI HD - Gastrointestinal Boundary Identification and Sizing Tube 40 French

  Reshape Lifesciences Inc.

  2022-08-07

• GIBI HD - Gastrointestinal Boundary Identification and Sizing Tube 36 French

  Reshape Lifesciences Inc.

  2022-08-07

• GIBI HD - Gastrointestinal Boundary Identification and Sizing Tube 32 French

  Reshape Lifesciences Inc.

  2022-08-07