510(k) Report

Devices descending from K221898

2 later devices reach Gastrointestinal Boundary Identifier (GIBI HD) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250389XNY Disposable Gastric Calibration TubeChangzhou Xin Neng Yuan Medical Stapler Co.,Ltd20250—
+1K230131ReShape Calibration TubesReshape Lifesciences20230—