NEZ
- Product code
- NEZ
- Device name
- System, Imaging, Gastrointestinal, Wireless, Capsule
- Device class
- Class 2
- 21 CFR
- 21 CFR 876.1300
- Medical specialty
- Gastroenterology, Urology
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 5
- Summaries archived here
- 5 (direct download)
- 510(k) clearances (all years, FDA)
- 47 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (5)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K252617 | 2026-05-08 | Intromedic Co., Ltd. | MiroCam® Capsule Endoscope System | |
| K252480 | 2025-12-19 | CapsoVision, Inc. | CE Deliver (DLV) | |
| K242643 | 2024-12-04 | CapsoVision, Inc. | CapsoCam Plus (SV-3) Capsule Endoscopy System | |
| K240276 | 2024-05-10 | Given Imaging Ltd. (D.B.A. Medtronic) | PillCam Genius SB System with PillCam Software v9.7… | |
| K233229 | 2024-01-05 | Anx Robotica Corporation | NaviCam Small Bowel Capsule Endoscopy System with Na… |
Official FDA classification page: NEZ
Classification and pathway per current FDA publications. Data from openFDA (CC0).