510(k) Report

Devices descending from DEN120023

7 later devices reach Given Pillcam Colon 2 Capsule Endoscopy System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K153466PillCam COLON 2 Capsule Endoscopy SystemGiven Imaging, Ltd.20165—
+1K140284Given Pillcam Ugi Capsule Endoscopy SystemGiven Imaging, Ltd.20140—
+2K170210PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0Given Imaging, Ltd.20174—
+3K211684PillCam SB 3 capsule endoscopy system, PillCam Software 9.0EGiven Imaging Ltd. (Medtronic)20213—
+4K242643CapsoCam Plus (SV-3) Capsule Endoscopy SystemCapsoVision, Inc.20240—
+4K230991PillCam SB 3 capsule endoscopy system, PillCam Software 9.0EGiven Imaging Ltd. (Medtronic)20231—
+5K240276PillCam™ Genius SB System with PillCam Software v9.7 and PillCam Cloud Reader SoftwareGiven Imaging Ltd. (D.B.A. Medtronic)20240—