Panels › Gastroenterology, Urology › Product code NEZ · Class 2
System, Imaging, Gastrointestinal, Wireless, Capsule
Regulation 876.1300
2510(k)s in 12 months (47 all time)
0recalls in 12 months (6 all time)
5recalls that name a 510(k)
Top companies in NEZ
| Company | 510(k)s | Recalls |
|---|---|---|
| Given Imaging , Ltd. | 19 | 2 |
| Intromedic Co., Ltd. | 8 | 1 |
| Olympus Medical Systems Corp. | 7 | 0 |
| CapsoVision, Inc. | 6 | 0 |
| Capso Vision, Inc. | 0 | 3 |
| Given Imaging Ltd. (Medtronic) | 2 | 0 |
| United States Endoscopy Group, Inc. | 2 | 0 |
| Ankon Technologies Co., Ltd. | 1 | 0 |
| Anx Robotica Corporation | 1 | 0 |
| Given Imaging Ltd. (D.B.A. Medtronic) | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 8, 2026 | K252617 | MiroCam® Capsule Endoscope System Intromedic Co., Ltd., KR | NEZ |
| Dec 19, 2025 | K252480 | CE Deliver (DLV) CapsoVision, Inc. | NEZ |
| Dec 4, 2024 | K242643 | CapsoCam Plus (SV-3) Capsule Endoscopy System CapsoVision, Inc. | NEZ |
| May 10, 2024 | K240276 | PillCam Genius SB System with PillCam Software v9.7 and PillCam Cloud Reader Software Given Imaging Ltd. (D.B.A. Medtronic), IL | NEZ |
| Jan 5, 2024 | K233229 | NaviCam Small Bowel Capsule Endoscopy System with NaviCam SB Capsule and NaviCam Tether Anx Robotica Corporation | NEZ |
| Jun 30, 2023 | K230991 | PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E Given Imaging Ltd. (Medtronic), IL | NEZ |
| Dec 2, 2022 | K221590 | NaviCam Small Bowel Capsule Endoscopy System Ankon Technologies Co., Ltd., CN | NEZ |
| Aug 27, 2021 | K211684 | PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E Given Imaging Ltd. (Medtronic), IL | NEZ |
| Feb 14, 2020 | K192662 | CapsoCam Plus (SV-3) Capsule Endoscopy System CapsoVision, Inc. | NEZ |
| Apr 19, 2019 | K183192 | CapsoCam Plus (SV-3) CapsoVision, Inc. | NEZ |
| Mar 5, 2019 | K183053 | Olympus Small Intestinal Capsule Endoscope System Olympus Medical Systems Corp., JP | NEZ |
| Nov 8, 2018 | K180732 | MiroCam Capsule Endoscope System Intromedic Co., Ltd., KR | NEZ |
| Mar 13, 2018 | K173459 | Olympus Small Intestinal Capsule Endoscope System Olympus Medical Systems Corp., JP | NEZ |
| Jan 30, 2018 | K170438 | MiroCam Capsule Endoscope System Intromedic Co., Ltd., KR | NEZ |
| Sep 1, 2017 | K170210 | PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0 Given Imaging , Ltd., IL | NEZ |
| May 26, 2017 | K170839 | RAPID Web Given Imaging , Ltd., IL | NEZ |
| Mar 10, 2017 | K163495 | AdvanCE capsule endoscope delivery device United States Endoscopy Group, Inc. | NEZ |
| Jan 19, 2017 | K163069 | OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM Olympus Medical Systems Corp., JP | NEZ |
| Oct 21, 2016 | K161773 | CapsoCam Plus (SV-3) Capsule Endoscope System CapsoVision, Inc. | NEZ |
| Feb 9, 2016 | K151635 | CapsoCam (SV-1) CapsoVision, Inc. | NEZ |
| Mar 17, 2015 | K143663 | MiroCam Capsule Endoscope System Intromedic Co., Ltd., KR | NEZ |
| Feb 8, 2015 | K142680 | ENDOCAPSULE SOFTWARE 10; ENDOCAPSULE SOFTWARE 10 LIGHT Olympus Medical Systems Corp., JP | NEZ |
| Dec 17, 2014 | K140284 | GIVEN PILLCAM UGI CAPSULE ENDOSCOPY SYSTEM Given Imaging , Ltd., IL | NEZ |
| Jul 9, 2014 | K134005 | MIROCAM CAPSULE ENDOSCOPE SYSTEM Intromedic Co., Ltd., KR | NEZ |
| Jun 30, 2014 | K140751 | MIROCAM CAPSULE ENDOSCOPE SYSTEM Intromedic Co., Ltd., KR | NEZ |
| Aug 12, 2013 | K123864 | GIVEN PILLCAM ENDOSCOPY SYSTEM WITH RAPID 8.0, GIVEN PILLCAM SB 3 CAPSULE ENDOSCOPY SYSTEM Given Imaging , Ltd., IL | NEZ |
| May 20, 2013 | K123428 | MIROCAM CAPSULE ENDOSCOPE SYSTEM Intromedic Co., Ltd., KR | NEZ |
| Apr 29, 2013 | K123421 | OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM Olympus Medical Systems Corp. | NEZ |
| May 18, 2012 | K111450 | MIROCAM CAPSULE ENDOSCOPE SYSTEM Intromedic Co., Ltd. | NEZ |
| May 13, 2011 | K103025 | GIVEN PILLCAM PLATFORM WITH RAPID 6.5 / GIVEN PILLCAM PLATFORM WITH PILLCAM ESO 3 CAPSULES Given Imaging , Ltd., IL | NEZ |
| Mar 7, 2011 | K101250 | GIVEN PILLCAM PLATFORM WITH PILLCAM SB CAPSULES Given Imaging , Ltd., IL | NEZ |
| Jan 14, 2011 | K103088 | GIVEN PILLCAM PLATFORM WITH PILLCAM SB CAPSULESWITH PILLCAM R SENSORBELT Given Imaging , Ltd., IL | NEZ |
| Sep 30, 2010 | K101200 | PILLCAM EXPRESS VIDEO CAPSULES DELIVERY DEVICE Given Imaging , Ltd., IL | NEZ |
| Jul 29, 2009 | K091405 | PILLCAM PLATFORM WITH PILLCAM SB CAPSULES WITH PILLCAM SENSORBELT Given Imaging , Ltd., IL | NEZ |
| Jul 29, 2009 | K090210 | MODIFICATION TO OLYMPUS CAPSULE ENDOSCOPE SYSTEM Olympus Medical Systems Corporation | NEZ |
| Sep 14, 2007 | K063259 | OLYMPUS CAPSULE ENDOSCOPE SYSTEM Olympus Medical Systems Corporation | NEZ |
| May 7, 2007 | K070475 | MODIFICATON TO: GIVEN DIAGNOSTIC IMAGING SYSTEM Given Imaging , Ltd., CA | NEZ |
| Oct 18, 2006 | K062786 | MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM Given Imaging , Ltd., IL | NEZ |
| May 8, 2006 | K053639 | GIVEN DIAGNOSTIC SYSTEM Given Imaging , Ltd., IL | NEZ |
| Jun 23, 2004 | K040494 | CAPSULE DELIVERY DEVICE, 160CM, MODEL 711143; CAPSULE DELIVERY DEVICE, 210CM, MODEL 711144 United States Endoscopy Group, Inc. | NEZ |
| Feb 17, 2004 | K040248 | MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM Given Imaging , Ltd., IL | NEZ |
| Oct 29, 2003 | K032405 | GIVEN DIAGNOSTIC SYSTEM Given Imaging , Ltd., IL | NEZ |
| Jul 1, 2003 | K031033 | GIVEN DIAGNOSTIC SYSTEM Given Imaging , Ltd., IL | NEZ |
| Feb 27, 2003 | K022980 | MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM Given Imaging , Ltd., IL | NEZ |
| Aug 9, 2002 | K022362 | GIVEN DIAGNOSTICS SYSTEM Given Imaging , Ltd., IL | NEZ |
| May 2, 2002 | K020341 | GIVEN DIAGNOSTIC SYSTEM Given Imaging , Ltd., IL | NEZ |
| Aug 1, 2001 | DEN010002 | GIVEN DIAGNOSTIC IMAGING SYSTEM Given Imaging , Ltd., IL | NEZ |
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