NEZ — System, Imaging, Gastrointestinal, Wireless, Capsule Class II
FDA Device Classification
Classification Details
- Product Code
- NEZ
- Device Class
- Class II
- Regulation Number
- 876.1300
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K252480 | capsovision | CE Deliver (DLV) | December 19, 2025 |
| K242643 | capsovision | CapsoCam Plus (SV-3) Capsule Endoscopy System | December 4, 2024 |
| K240276 | given imaging ltd. (d.b.a. medtronic) | PillCam Genius SB System with PillCam Software v9.7 and PillCam Cloud Reader So | May 10, 2024 |
| K233229 | anx robotica corporation | NaviCam Small Bowel Capsule Endoscopy System with NaviCam SB Capsule and NaviCam | January 5, 2024 |
| K230991 | given imaging ltd. (medtronic) | PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E | June 30, 2023 |
| K221590 | ankon technologies co | NaviCam Small Bowel Capsule Endoscopy System | December 2, 2022 |
| K211684 | given imaging ltd. (medtronic) | PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E | August 27, 2021 |
| K192662 | capsovision | CapsoCam Plus (SV-3) Capsule Endoscopy System | February 14, 2020 |
| K183192 | capsovision | CapsoCam Plus (SV-3) | April 19, 2019 |
| K183053 | olympus medical systems | Olympus Small Intestinal Capsule Endoscope System | March 5, 2019 |
| K180732 | intromedic co | MiroCam Capsule Endoscope System | November 8, 2018 |
| K173459 | olympus medical systems | Olympus Small Intestinal Capsule Endoscope System | March 13, 2018 |
| K170438 | intromedic co | MiroCam Capsule Endoscope System | January 30, 2018 |
| K170210 | given imaging | PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0 | September 1, 2017 |
| K170839 | given imaging | RAPID Web | May 26, 2017 |
| K163495 | united states endoscopy group | AdvanCE capsule endoscope delivery device | March 10, 2017 |
| K163069 | olympus medical systems | OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM | January 19, 2017 |
| K161773 | capsovision | CapsoCam Plus (SV-3) Capsule Endoscope System | October 21, 2016 |
| K151635 | capsovision | CapsoCam (SV-1) | February 9, 2016 |
| K143663 | intromedic co | MiroCam Capsule Endoscope System | March 17, 2015 |