Reshape Lifesciences FDA Approvals

0 new drug approvals and 4 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
ReShape Calibration Tubes (B-2032, B-2036, B-2040); ReShape Calibration Tubes (B-2017); Gastric Balloon Suction Catheter (B-2020)510(k)May 16, 2024Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Special)	May 16, 2024
ReShape Calibration Tubes510(k)Feb 15, 2023Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Special)	Feb 15, 2023
Gastrointestinal Boundary Identifier (GIBI HD)510(k)Jul 28, 2022Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Special)	Jul 28, 2022
Lap-Band System Calibration Tube510(k)Jun 7, 2022Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Jun 7, 2022