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Sign in to claim this brandReShape Lifesciences Inc.
US
Last updated May 24, 2026
What ReShape Lifesciences Inc. makes
The company manufactures laparoscopic gastric band systems, including adjustable bands with access ports for fluid adjustments, calibration tubes for band sizing, and repair kits for device maintenance. It also produces subcutaneous infusion ports, needles for port access, and applicators for securing ports or tacks during surgical placement.
These devices are regulated under US FDA classifications, with most falling into Class II and some into Class III, requiring Premarket Approval (PMA) or Unique Device Identification (UDI) registration. The company’s products are listed under the FDA’s PMA and UDI programs, reflecting their authorised status for use in weight management procedures.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does ReShape Lifesciences Inc. manufacture?
ReShape Lifesciences Inc. specializes in laparoscopic weight management devices. Its portfolio includes adjustable gastric bands, access port kits for fluid adjustments, calibration tubes for sizing the band, subcutaneous infusion ports, needles for accessing ports, and applicators for securing ports or tacks during surgery. These devices are designed for use in bariatric procedures to aid weight loss.
Where is ReShape Lifesciences Inc. based?
ReShape Lifesciences Inc. is headquartered in the United States. The company focuses on developing and manufacturing medical devices primarily for weight management and bariatric surgery applications.
Which regulatory registries or programs list ReShape Lifesciences Inc.’s devices?
ReShape Lifesciences Inc.’s devices are listed under the US Food and Drug Administration’s (FDA) Premarket Approval (PMA) and Unique Device Identification (UDI) programs. These registries ensure compliance with FDA requirements for medical devices, particularly for those classified as Class II or Class III.
How are ReShape Lifesciences Inc.’s devices classified under FDA regulations?
ReShape Lifesciences Inc.’s devices are primarily classified as Class II or Class III under FDA regulations. Class II devices generally pose moderate risk and require special controls to ensure safety and effectiveness, while Class III devices, such as some gastric bands, are higher risk and require Premarket Approval (PMA) to demonstrate safety and performance before they can be marketed.
What is the purpose of the devices manufactured by ReShape Lifesciences Inc.?
The devices manufactured by ReShape Lifesciences Inc. are intended for use in bariatric surgery to aid in weight loss. These include adjustable gastric bands that restrict stomach capacity, access ports for making fluid adjustments to the band, calibration tubes for proper sizing, and tools for surgical placement and maintenance, such as infusion ports and applicators. These devices work together to help patients manage obesity through surgical intervention.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- obalon.com
- —
- —
- [email protected]
- Phone
- 1-844-362-2566
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 022894714
Catalogue (59)
Page 1 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| ReShape Calibration Tubes™ | B-2017 | FDA UDI | Class II | Active |
| Obalon® | 7402-0001 | FDA UDI | Class III | Unknown |
| Gastric Balloon Suction Catheter | B-2020 | FDA UDI | Class II | Active |
| OBALON® Placebo Capsule | 7150-0003 | FDA UDI | Class III | Unknown |
| OBALON® Placebo Capsule HPMC | 7650-0002 | FDA UDI | Class III | Unknown |
| ReShape Calibration Tubes | B-2032 | FDA UDI | Class II | Active |
| Gibi Hd | B-2036 | FDA UDI | Class II | Unknown |
| Model 2002 Maestro Rechargeable Neuroregulator | 2002 | FDA UDI | Class III | Unknown |
| LAP-BAND® AP System Standard with RapidPort® EZ | C-2360 | FDA UDI | Class III | Active |
| ReShape Lap-Band® 2.0 FLEX, Large | D-3365 | FDA UDI | Class III | Active |
| RapidPort® EZ Access Port Kit for use with LAP-BAND® AP System Large | C-2306 | FDA UDI | Class III | Active |
| LAP-BAND® System Access Port Needle, 20G x 89 mm (3.5 in.) | B-20301-10 | FDA UDI | Class III | Active |
| ReShape Lap-Band® 2.0 FLEX, Standard | D-3360 | FDA UDI | Class III | Active |
| ReShape Lap-Band® 2.0, FLEX & Access Port, Standard | D-3304 | FDA UDI | Class III | Active |
| Gibi Hd | B-2040 | FDA UDI | Class II | Unknown |
| Model 2004 Maestro Implant Kit | 2004 | FDA UDI | Class III | Unknown |
| Model 2403-60 Maestro Patient Transmit Coil | 2403-60 | FDA UDI | Class III | Unknown |
| Model 1660 Maestro Patient Transmit Coil Belt | 1660 | FDA UDI | Class III | Unknown |
| Model 2502 Maestro Clinician Programmer | 2502 | FDA UDI | Class III | Unknown |
| Obalon® | 6200-0001 | FDA UDI | Class III | Unknown |
| Model 2200A-47E Maestro Anterior Lead | 2200A-47E | FDA UDI | Class III | Unknown |
| Model 1680 Torque Wrench | 1680 | FDA UDI | Class III | Unknown |
| ReShape Calibration Tubes | B-2036 | FDA UDI | Class II | Active |
| Model 1600 Maestro Programmer Cable | 1600 | FDA UDI | Class III | Unknown |
| OBALON Touch™ | 4300-0003 | FDA UDI | Class III | Unknown |
| LAP-BAND® AP System Large with RapidPort® EZ | C-2365 | FDA UDI | Class III | Active |
| OBALON® EzFill™ Dispenser | 4200-0001 | FDA UDI | Class III | Unknown |
| Model 1620 AC Recharger | 1620 | FDA UDI | Class III | Unknown |
| Obalon® | 7405-0001 | FDA UDI | Class III | Unknown |
| OBALON® Inflation Can | 8200-0001 | FDA UDI | Class III | Unknown |
| OBALON® Balloon Kit HPMC | 7600-0001 | FDA UDI | Class III | Unknown |
| Model 2402 Maestro Mobile Charger | 2402 | FDA UDI | Class III | Unknown |
| ReShape Lap-Band® 2.0, FLEX & Access Port, Large | D-3306 | FDA UDI | Class III | Active |
| OBALON® Balloon Kit | 7500-0001 | FDA UDI | Class III | Unknown |
| Gibi Hd | B-2032 | FDA UDI | Class II | Unknown |
| OBALON® EzFill™ Can | 8200-0001 | FDA UDI | Class III | Unknown |
| LAP-BAND® System Calibration Tube | B-2017 | FDA UDI | Class II | Unknown |
| LAP-BAND® System Access Port Needle, 20G x 51 mm (2 in.) | B-20302-10 | FDA UDI | Class III | Active |
| RapidPort® EZ Access Port Kit for use with LAP-BAND® AP System Standard | C-2304 | FDA UDI | Class III | Active |
| OBALON® Accessory Kit | 6000-0004 | FDA UDI | Class III | Unknown |
| Obalon® | 9410-0001 | FDA UDI | Class III | Unknown |
| Model 2404 Maestro Patient Kit | 2404 | FDA UDI | Class III | Unknown |
| Model 2200P-47E Maestro Posterior Lead | 2200P-47E | FDA UDI | Class III | Unknown |
| Model 2504 Maestro Clinician Programmer Kit | 2504 | FDA UDI | Class III | Unknown |
| Model 2403-300 Maestro Clinician Transmit Coil | 2403-300 | FDA UDI | Class III | Unknown |
| Obalon Aspiration Adapter | 6100-0004 | FDA UDI | Class I | Unknown |
| OBALON® Balloon System | 9500-0001 | FDA UDI | Class III | Unknown |
| Obalon® | 7404-0001 | FDA UDI | Class III | Unknown |
| Obalon® | 6300-0001 | FDA UDI | Class III | Unknown |
| OBALON Touch™ | 9300-0001 | FDA UDI | Class III | Unknown |
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