NEZ — System, Imaging, Gastrointestinal, Wireless, Capsule Class II
FDA product code NEZ covers "System, Imaging, Gastrointestinal, Wireless, Capsule", a Class II medical device regulated under 21 CFR 876.1300. Submissions are reviewed by the Gastroenterology, Urology panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |
|---|---|---|---|
| K252617 | intromedic co | MiroCam® Capsule Endoscope System | May 8, 2026 |
| 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 |