Medical Device Manufacturer · US , San Clemente , CA

Reshape Lifesciences - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 2022

Recent clearances: ReShape Calibration Tubes (B-2032, B-2036, B-2040), ReShape Calibration Tubes, Gastrointestinal Boundary Identifier (GIBI HD)

4

Total

4

Cleared

0

Denied

FDA 510(k) Regulatory Record - Reshape Lifesciences Gastroenterology & Urology ✕

4 devices

1-4 of 4

Cleared May 16, 2024

ReShape Calibration Tubes (B-2032, B-2036, B-2040)

Gastroenterology & Urology · 30d

Cleared Feb 15, 2023

ReShape Calibration Tubes

Gastroenterology & Urology · 29d

Cleared Jul 28, 2022

Gastrointestinal Boundary Identifier (GIBI HD)

Gastroenterology & Urology · 28d

Cleared Jun 07, 2022

Lap-Band System Calibration Tube

Gastroenterology & Urology · 110d