Product code NEZ
- Device name
- System, Imaging, Gastrointestinal, Wireless, Capsule
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.1300
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252617 | MiroCam® Capsule Endoscope System | Intromedic Co., Ltd. | 2026-05-08 |
| K252480 | CE Deliver (DLV) | CapsoVision, Inc. | 2025-12-19 |
| K242643 | CapsoCam Plus (SV-3) Capsule Endoscopy System | CapsoVision, Inc. | 2024-12-04 |
| K240276 | PillCam™ Genius SB System with PillCam Software v9.7 and PillCam Cloud Reader Software | Given Imaging Ltd. (D.B.A. Medtronic) | 2024-05-10 |
| K233229 | NaviCam Small Bowel Capsule Endoscopy System with NaviCam SB Capsule and NaviCam Tether | Anx Robotica Corporation | 2024-01-05 |
| K230991 | PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E | Given Imaging Ltd. (Medtronic) | 2023-06-30 |
| K221590 | NaviCam Small Bowel Capsule Endoscopy System | Ankon Technologies Co., Ltd. | 2022-12-02 |
| K211684 | PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E | Given Imaging Ltd. (Medtronic) | 2021-08-27 |
| K192662 | CapsoCam Plus (SV-3) Capsule Endoscopy System | CapsoVision, Inc. | 2020-02-14 |
| K183192 | CapsoCam Plus (SV-3) | CapsoVision, Inc. | 2019-04-19 |
| K183053 | Olympus Small Intestinal Capsule Endoscope System | Olympus Medical Systems Corp. | 2019-03-05 |
| K180732 | MiroCam Capsule Endoscope System | Intromedic Co., Ltd. | 2018-11-08 |
| K173459 | Olympus Small Intestinal Capsule Endoscope System | Olympus Medical Systems Corp. | 2018-03-13 |
| K170438 | MiroCam Capsule Endoscope System | Intromedic Co., Ltd. | 2018-01-30 |
| K170210 | PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0 | Given Imaging , Ltd. | 2017-09-01 |
| K170839 | RAPID Web | Given Imaging , Ltd. | 2017-05-26 |
| K163495 | AdvanCE capsule endoscope delivery device | United States Endoscopy Group, Inc. | 2017-03-10 |
| K163069 | OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM | Olympus Medical Systems Corp. | 2017-01-19 |
| K161773 | CapsoCam Plus (SV-3) Capsule Endoscope System | CapsoVision, Inc. | 2016-10-21 |
| K151635 | CapsoCam (SV-1) | CapsoVision, Inc. | 2016-02-09 |
| K143663 | MiroCam Capsule Endoscope System | Intromedic Co., Ltd. | 2015-03-17 |
| K142680 | ENDOCAPSULE SOFTWARE 10; ENDOCAPSULE SOFTWARE 10 LIGHT | Olympus Medical Systems Corp. | 2015-02-08 |
| K140284 | GIVEN PILLCAM UGI CAPSULE ENDOSCOPY SYSTEM | Given Imaging , Ltd. | 2014-12-17 |
| K134005 | MIROCAM CAPSULE ENDOSCOPE SYSTEM | Intromedic Co., Ltd. | 2014-07-09 |
| K140751 | MIROCAM CAPSULE ENDOSCOPE SYSTEM | Intromedic Co., Ltd. | 2014-06-30 |
| K123864 | GIVEN PILLCAM ENDOSCOPY SYSTEM WITH RAPID 8.0, GIVEN PILLCAM SB 3 CAPSULE ENDOSCOPY SYSTEM | Given Imaging , Ltd. | 2013-08-12 |
| K123428 | MIROCAM CAPSULE ENDOSCOPE SYSTEM | Intromedic Co., Ltd. | 2013-05-20 |
| K123421 | OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM | Olympus Medical Systems Corp. | 2013-04-29 |
| K111450 | MIROCAM CAPSULE ENDOSCOPE SYSTEM | Intromedic Co., Ltd. | 2012-05-18 |
| K103025 | GIVEN PILLCAM PLATFORM WITH RAPID 6.5 / GIVEN PILLCAM PLATFORM WITH PILLCAM ESO 3 CAPSULES | Given Imaging , Ltd. | 2011-05-13 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 04953170360817 | ENDOCAPSULE SOFTWARE 10 SOFT SERVER-CLIENT | OLYMPUS MEDICAL SYSTEMS CORP. | 2023-06-21 |
| 04953170360824 | ENDOCAPSULE SOFTWARE 10 SOFTWARE CLIENT | OLYMPUS MEDICAL SYSTEMS CORP. | 2023-06-21 |
| 00867770000223 | CapsoCloud | CAPSOVISION, INC. | 2020-03-02 |
| 07290101369530 | PillCam | Given Imaging, Inc. | 2019-08-11 |
| 00867770000216 | CapsoView | CAPSOVISION, INC. | 2018-07-17 |
| 07290101366768 | PillCam | Given Imaging, Inc. | 2018-03-21 |
| 07290101366751 | PillCam | Given Imaging, Inc. | 2018-03-21 |
| 07290101366904 | Pillcam | Given Imaging, Inc. | 2017-02-01 |
| 07290101366058 | RAPID | Given Imaging, Inc. | 2017-02-01 |
| 07290101364993 | RAPID | Given Imaging, Inc. | 2016-09-24 |
| 07290101366478 | RAPID | Given Imaging, Inc. | 2016-09-24 |
| 07290101366461 | RAPID | Given Imaging, Inc. | 2016-09-24 |
| 07290101365280 | RAPID | Given Imaging, Inc. | 2016-09-24 |
| 07290101365273 | RAPID | Given Imaging, Inc. | 2016-09-24 |
| 07290101365266 | RAPID | Given Imaging, Inc. | 2016-09-24 |
| 07290101365013 | RAPID | Given Imaging, Inc. | 2016-09-24 |
| 07290101365006 | RAPID | Given Imaging, Inc. | 2016-09-24 |
| 07290101364870 | RAPID | Given Imaging, Inc. | 2016-09-24 |
| 07290101364863 | RAPID | Given Imaging, Inc. | 2016-09-24 |
| 07290101364856 | RAPID | Given Imaging, Inc. | 2016-09-24 |
| 07290101364207 | RAPID | Given Imaging, Inc. | 2016-09-24 |
| 07290101364184 | RAPID | Given Imaging, Inc. | 2016-09-24 |
| 07290101363477 | RAPID | Given Imaging, Inc. | 2016-09-24 |
| 07290101362784 | RAPID | Given Imaging, Inc. | 2016-09-24 |
| 07290101362265 | RAPID | Given Imaging, Inc. | 2016-09-24 |
| 07290101362234 | RAPID | Given Imaging, Inc. | 2016-09-24 |
| 07290101362128 | RAPID | Given Imaging, Inc. | 2016-09-24 |
| 04953170373763 | ENDOCAPSULE SOFTWARE 10 | OLYMPUS MEDICAL SYSTEMS CORP. | 2016-09-21 |
| 04953170373848 | ENDOCAPSULE SOFTWARE 10 UPGRADE PACKAGE | OLYMPUS MEDICAL SYSTEMS CORP. | 2016-09-21 |
| 04953170373800 | ENDOCAPSULE SOFTWARE 10 LIGHT | OLYMPUS MEDICAL SYSTEMS CORP. | 2016-09-21 |