# Reshape Lifesciences

- Location (FDA's records): San Clemente, CA
- FDA decisions: 5 (2015–2024): 4 510(k) clearances and 1 original PMA approval
- Names in FDA's records: Reshape Lifesciences (4); Reshape Lifesciences, Inc. (1)
- Product codes: KNT (4), PIM (1)
- 510(k) review time since 2016: median 30 days, against 110 for FDA's reviews in the same codes and years (3 of 4 faster)
- Predicates its devices cite: 4 (3 its own); citations of its devices by later devices: 4 (3 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Bioenterics Corp.: 1 (https://510kreport.com/company/bioenterics)

## Firms that cite its devices most
- Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd: 1 (https://510kreport.com/company/changzhou-xin-neng-yuan-medical-stapler)

## Its most-cited devices
- K221898: Gastrointestinal Boundary Identifier (GIBI HD) (2022), cited by 2
- K220455: Lap-Band System Calibration Tube (2022), cited by 2

## Recent decisions
- K241039: ReShape Calibration Tubes (B-2032, B-2036, B-2040); ReShape Calibration Tubes (B-2017); Gastric Balloon Suction Catheter (B-2020) (May 16, 2024)
- K230131: ReShape Calibration Tubes (Feb 15, 2023)
- K221898: Gastrointestinal Boundary Identifier (GIBI HD) (Jul 28, 2022)
- K220455: Lap-Band System Calibration Tube (Jun 7, 2022)
- P130019: Maestro Rechargeable System (Jan 14, 2015)

Source page: https://510kreport.com/company/reshape-lifesciences