K241039
- 510(k) number
- K241039
- Device name
- ReShape Calibration Tubes (B-2032, B-2036, B-2040); ReShape Calibration Tubes (B-2017); Gastric Balloon Suction Catheter (B-2020)
- Applicant
- Reshape Lifesciences CA · US
- Product code
- KNT — Tubes, Gastrointestinal (And Accessories)
- Decision date
- 2024-05-16
- Date received
- 2024-04-16
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K241039.pdf
Official FDA record: K241039
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.