NEZ · System, Imaging, Gastrointestinal, Wireless, Capsule
Gastroenterology, Urology · 21 CFR 876.1300 · Class 2
Overview
| Product Code | NEZ |
|---|---|
| Device Name | System, Imaging, Gastrointestinal, Wireless, Capsule |
| Regulation | 21 CFR 876.1300 |
| Device Class | Class 2 |
| Review Panel | Gastroenterology, Urology |
Identification
An ingestible telemetric gastrointestinal capsule imaging system is used for visualization of the small bowel mucosa as an adjunctive tool in the detection of abnormalities of the small bowel. The device captures images of the small bowel with a wireless camera contained in a capsule. This device includes an ingestible capsule (containing a light source, camera, transmitter, and battery), an antenna array, a receiving/recording unit, a data storage device, computer software to process the images, and accessories.
Classification Rationale
Class II (special controls). The special control is FDA's guidance, “Class II Special Controls Guidance Document: Ingestible Telemetric Gastrointestinal Capsule Imaging Systems; Final Guidance for Industry and FDA.”
Special Controls
*Classification.* Class II (special controls). The special control is FDA's guidance, “Class II Special Controls Guidance Document: Ingestible Telemetric Gastrointestinal Capsule Imaging Systems; Final Guidance for Industry and FDA.”
Recent Cleared Devices (20 of 46)
Showing 20 most recent of 46 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K252480 | CE Deliver (DLV) | CapsoVision, Inc. | Dec 19, 2025 | SESE |
| K242643 | CapsoCam Plus (SV-3) Capsule Endoscopy System | CapsoVision, Inc. | Dec 4, 2024 | SESE |
| K240276 | PillCam Genius SB System with PillCam Software v9.7 and PillCam Cloud Reader Software | Given Imaging Ltd. (D.B.A. Medtronic) | May 10, 2024 | SESE |
| K233229 | NaviCam Small Bowel Capsule Endoscopy System with NaviCam SB Capsule and NaviCam Tether | Anx Robotica Corporation | Jan 5, 2024 | SESE |
| K230991 | PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E | Given Imaging Ltd. (Medtronic) | Jun 30, 2023 | SESE |
| K221590 | NaviCam Small Bowel Capsule Endoscopy System | Ankon Technologies Co., Ltd. | Dec 2, 2022 | SESE |
| K211684 | PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E | Given Imaging Ltd. (Medtronic) | Aug 27, 2021 | SESE |
| K192662 | CapsoCam Plus (SV-3) Capsule Endoscopy System | CapsoVision, Inc. | Feb 14, 2020 | SESE |
| K183192 | CapsoCam Plus (SV-3) | CapsoVision, Inc. | Apr 19, 2019 | SESE |
| K183053 | Olympus Small Intestinal Capsule Endoscope System | Olympus Medical Systems Corp. | Mar 5, 2019 | SESE |
| K180732 | MiroCam Capsule Endoscope System | Intromedic Co., Ltd. | Nov 8, 2018 | SESE |
| K173459 | Olympus Small Intestinal Capsule Endoscope System | Olympus Medical Systems Corp. | Mar 13, 2018 | SESE |
| K170438 | MiroCam Capsule Endoscope System | Intromedic Co., Ltd. | Jan 30, 2018 | SESE |
| K170210 | PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0 | Given Imaging , Ltd. | Sep 1, 2017 | SESE |
| K170839 | RAPID Web | Given Imaging , Ltd. | May 26, 2017 | SESE |
| K163495 | AdvanCE capsule endoscope delivery device | United States Endoscopy Group, Inc. | Mar 10, 2017 | SESE |
| K163069 | OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM | Olympus Medical Systems Corp. | Jan 19, 2017 | SESE |
| K161773 | CapsoCam Plus (SV-3) Capsule Endoscope System | CapsoVision, Inc. | Oct 21, 2016 | SESE |
| K151635 | CapsoCam (SV-1) | CapsoVision, Inc. | Feb 9, 2016 | SESE |
| K143663 | MiroCam Capsule Endoscope System | Intromedic Co., Ltd. | Mar 17, 2015 | SESE |
Top Applicants
- Given Imaging , Ltd. — 19 clearances
- Intromedic Co., Ltd. — 7 clearances
- CapsoVision, Inc. — 6 clearances
- Olympus Medical Systems Corp. — 5 clearances
- Given Imaging Ltd. (Medtronic) — 2 clearances
