FDA product code NEZ: System, Imaging, Gastrointestinal, Wireless, Capsule
NEZ is the FDA product code for system, imaging, gastrointestinal, wireless, capsule. It is a Class II device, regulated under 21 CFR 876.1300 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 46 510(k) submissions under NEZ, 7 in the last five years, from 10 different applicants. The average 510(k) review took 151 days (median 128); 164 days on average over the last three years. 1 De Novo request was granted under it. FDA has posted 6 recalls for NEZ devices.
Classification
| Field | Value |
|---|---|
| Device name | System, Imaging, Gastrointestinal, Wireless, Capsule |
| Device class | Class II |
| Regulation | 21 CFR 876.1300 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
510(k) clearances per year for NEZ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 4 | 113 |
| 2018 | 3 | 237 |
| 2019 | 2 | 137 |
| 2020 | 1 | 142 |
| 2021 | 1 | 87 |
| 2022 | 1 | 183 |
| 2023 | 1 | 85 |
| 2024 | 3 | 97 |
| 2025 | 1 | 134 |
| 2026 | 1 | 262 |
Compare with all 510(k) review times · Search every NEZ clearance
Top NEZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Given Imaging , Ltd. | 18 | 2017-09-01 |
| Intromedic Co., Ltd. | 8 | 2026-05-08 |
| CapsoVision, Inc. | 6 | 2025-12-19 |
| Olympus Medical Systems Corp. | 5 | 2019-03-05 |
| Given Imaging Ltd. (Medtronic) | 2 | 2023-06-30 |
5 more applicants have NEZ clearances. See the full list in Caduvo.
Most recent NEZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252617 | Intromedic Co., Ltd. | MiroCam® Capsule Endoscope System | 2026-05-08 | 262 |
| K252480 | CapsoVision, Inc. | CE Deliver (DLV) | 2025-12-19 | 134 |
| K242643 | CapsoVision, Inc. | CapsoCam Plus (SV-3) Capsule Endoscopy System | 2024-12-04 | 92 |
| K240276 | Given Imaging Ltd. (D.B.A. Medtronic) | PillCam Genius SB System with PillCam Software v9.7 and PillCam Cloud Reader Software | 2024-05-10 | 100 |
| K233229 | Anx Robotica Corporation | NaviCam Small Bowel Capsule Endoscopy System with NaviCam SB Capsule and NaviCam Tether | 2024-01-05 | 99 |
Recalls for NEZ devices
6 product recalls in 6 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2020-02-26.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2019 | 2 |
| 2020 | 1 |
Frequently asked questions
What is FDA product code NEZ?
NEZ is the FDA product code for system, imaging, gastrointestinal, wireless, capsule. It is a Class II device, regulated under 21 CFR 876.1300 and reviewed by the Gastroenterology and Urology panel.
What device class is NEZ?
Class II, regulation 21 CFR 876.1300. Typical premarket route: 510(k).
How long does a 510(k) take for product code NEZ?
Across 46 cleared submissions the average was 151 days from receipt to decision (median 128).
Which companies have the most NEZ clearances?
Given Imaging , Ltd. (18); Intromedic Co., Ltd. (8); CapsoVision, Inc. (6); Olympus Medical Systems Corp. (5); Given Imaging Ltd. (Medtronic) (2).
Have NEZ devices been recalled?
Yes: 6 product recalls across 6 recall events; the most recent began 2020-02-26.
Next steps
- Run an FDA pathway report with predicate devices for product code NEZ
- Run a recall and safety report across every NEZ manufacturer
- Watch product code NEZ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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