FDA.reportPublic FDA data

510(k) K240276

Device
PillCam? Genius SB System with PillCam Software v9.7 and PillCam Cloud Reader Software
Applicant
Given Imaging Ltd. (D.B.A. Medtronic)
510(k) number
K240276
Product code
NEZ
Decision
Substantially Equivalent (SESE)
Decision date
2024-05-10
Date received
2024-01-31
Regulation
876.1300
Classification name
System, Imaging, Gastrointestinal, Wireless, Capsule
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Aaron Niklaus
Address
2 Hacarmel St. New Industrial Park P.O. Box 258 Yoqneam Northern IL 20692 20692

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code NEZ#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K252617MiroCam® Capsule Endoscope SystemIntromedic Co., Ltd.2026-05-08
K252480CE Deliver (DLV)CapsoVision, Inc.2025-12-19
K242643CapsoCam Plus (SV-3) Capsule Endoscopy SystemCapsoVision, Inc.2024-12-04
K233229NaviCam Small Bowel Capsule Endoscopy System with NaviCam SB Capsule and NaviCam TetherAnx Robotica Corporation2024-01-05
K230991PillCam SB 3 capsule endoscopy system, PillCam Software 9.0EGiven Imaging Ltd. (Medtronic)2023-06-30
K221590NaviCam Small Bowel Capsule Endoscopy SystemAnkon Technologies Co., Ltd.2022-12-02
K211684PillCam SB 3 capsule endoscopy system, PillCam Software 9.0EGiven Imaging Ltd. (Medtronic)2021-08-27
K192662CapsoCam Plus (SV-3) Capsule Endoscopy SystemCapsoVision, Inc.2020-02-14
K183192CapsoCam Plus (SV-3)CapsoVision, Inc.2019-04-19
K183053Olympus Small Intestinal Capsule Endoscope SystemOlympus Medical Systems Corp.2019-03-05
K180732MiroCam Capsule Endoscope SystemIntromedic Co., Ltd.2018-11-08
K173459Olympus Small Intestinal Capsule Endoscope SystemOlympus Medical Systems Corp.2018-03-13
K170438MiroCam Capsule Endoscope SystemIntromedic Co., Ltd.2018-01-30
K170210PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0Given Imaging , Ltd.2017-09-01
K170839RAPID WebGiven Imaging , Ltd.2017-05-26