FDA.reportPublic FDA data

510(k) K230991

Device
PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E
Applicant
Given Imaging Ltd. (Medtronic)
510(k) number
K230991
Product code
NEZ
Decision
Substantially Equivalent (SESE)
Decision date
2023-06-30
Date received
2023-04-06
Regulation
876.1300
Classification name
System, Imaging, Gastrointestinal, Wireless, Capsule
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Breanna Hessler
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
K240276PillCamâ„¢ Genius SB System with PillCam Software v9.7 and PillCam Cloud Reader SoftwareGiven Imaging Ltd. (D.B.A. Medtronic)2024-05-10
K233229NaviCam Small Bowel Capsule Endoscopy System with NaviCam SB Capsule and NaviCam TetherAnx Robotica Corporation2024-01-05
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