510(k) Report

Devices descending from K211684

3 later devices reach PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242643CapsoCam Plus (SV-3) Capsule Endoscopy SystemCapsoVision, Inc.20240—
+1K230991PillCam SB 3 capsule endoscopy system, PillCam Software 9.0EGiven Imaging Ltd. (Medtronic)20231—
+2K240276PillCam™ Genius SB System with PillCam Software v9.7 and PillCam Cloud Reader SoftwareGiven Imaging Ltd. (D.B.A. Medtronic)20240—