Panels › Gastroenterology, Urology › Product code NEZ · Class 2
System, Imaging, Gastrointestinal, Wireless, Capsule
Regulation 876.1300
2510(k)s in 12 months (47 all time)
0recalls in 12 months (6 all time)
5recalls that name a 510(k)
Top companies in NEZ
| Company | 510(k)s | Recalls |
|---|---|---|
| Given Imaging , Ltd. | 19 | 2 |
| Intromedic Co., Ltd. | 8 | 1 |
| Olympus Medical Systems Corp. | 7 | 0 |
| CapsoVision, Inc. | 6 | 0 |
| Capso Vision, Inc. | 0 | 3 |
| Given Imaging Ltd. (Medtronic) | 2 | 0 |
| United States Endoscopy Group, Inc. | 2 | 0 |
| Ankon Technologies Co., Ltd. | 1 | 0 |
| Anx Robotica Corporation | 1 | 0 |
| Given Imaging Ltd. (D.B.A. Medtronic) | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 26, 2020 | Capso Vision, Inc. The CapsoCam Plus (SV-3); Device Common Name: System, Imaging, Gastrointestinal, Wireless, Capsule; Catalog Number 2795 - Product Usage: intended for visualization of the small bowel mucosa in adults. Terminated |
NEZ | K192662 |
| Oct 18, 2019 | Capso Vision, Inc. CapsoCAM Plus, UDI: 00867770000209 Terminated |
NEZ | K183192 |
| Jul 3, 2019 | Capso Vision, Inc. CapsoCam Plus *** System, Imaging, Gastrointestinal, Wireless, Capsule, Electrical Rating 3.1V DC/10mA REF 2795 - Product Usage: The CapsoCam Plus video capsule system is intended for visualization of Terminated |
NEZ | K183192 |
| Feb 15, 2017 | IntroMedic Co., Ltd. Miriam Capsule Endoscope System. Model MR1100
Product Usage:
MiroCam Capsule Endoscope System is intended for visualization of the small bowel mucosa. It may be used as a tool in the detection of abn Terminated |
NEZ | K123428 |
| Mar 23, 2011 | Given Imaging Ltd. Given Imaging Limited, PillCam Express Delivery Device, For use with PillCam SB, endoscopic imaging device. Part numbers FGS-0367 (3-Pak) or FGS-0366 (1-Pak). Terminated |
NEZ | K101200 |
| Aug 20, 2008 | Given Imaging Inc Given Diagnostic System with PillCam SB Capsule - Gastrointestinal capsule imaging system. The device is an ingestible telemetric gastrointestinal capsule imaging system is used for visualization of Terminated |
NEZ | None listed |
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