510(k) Report

Devices descending from K220455

4 later devices reach Lap-Band System Calibration Tube through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241039ReShape Calibration Tubes (B-2032, B-2036, B-2040); ReShape Calibration Tubes (B-2017)…Reshape Lifesciences20240—
+1K221898Gastrointestinal Boundary Identifier (GIBI HD)Reshape Lifesciences20222—
+2K250389XNY Disposable Gastric Calibration TubeChangzhou Xin Neng Yuan Medical Stapler Co.,Ltd20250—
+2K230131ReShape Calibration TubesReshape Lifesciences20230—