System, Imaging, Gastrointestinal, Wireless, Capsule
Sensor Array DR2 (JP)
1manufacturer
3catalogue numbers in this listing
19510(k) clearances naming this product code
2recalls on this code
Who Else Makes It
Registered in Hubei. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Ankon Technologies Co., Ltd. | Wuhan | Hubei | Contract manufacturer | 2 |
Record
| Listed by | Given Imaging Ltd., Israel |
|---|---|
| FDA product code | NEZ |
| Device type | System, Imaging, Gastrointestinal, Wireless, Capsule |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1300 |
| Establishment | Manufacturer |
| Record published | 2016-09-24 |
| Record revised | 2024-07-03 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | lot or batch number, serial number |
| Storage | Special storage condition: Keep dry;Fragile |
| Distribution end date | 2021-03-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FGS-0193-J | Withdrawn | |
| FGS-0268-J | Withdrawn | |
| FGS-0272-J | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Pillcam | Given Imaging Ltd. | 65 |
| Rapid | Given Imaging Ltd. | 21 |
| MiroCam Capsule Endoscope System | IntroMedic Co., Ltd. | 15 |
| PillCam | Covidien LP | 9 |
| NaviCam Small Bowel Capsule Endoscopy System | Ankon Technologies Co., Ltd. | 5 |
| PillCam Genius | Given Imaging Ltd. | 3 |
| AdvanCE | Us Endoscopy | 2 |
| MiroCam Capusle Endoscope System | IntroMedic Co., Ltd. | 2 |
| CapsoCam Plus | CapsoVision, Inc. | 2 |
| CapsoRetrieve | CapsoVision, Inc. | 2 |
| CapsoView | CapsoVision, Inc. | 1 |
| NaviCam Data Recorder | ANX Robotica Corp. | 1 |
Showing 12 of 44. All products under System, Imaging, Gastrointestinal, Wireless, Capsule
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K170210 | 2017-09-01 |
| K170839 | 2017-05-26 |
| K140284 | 2014-12-17 |
| K123864 | 2013-08-12 |
| K103025 | 2011-05-13 |
| K101250 | 2011-03-07 |
| K103088 | 2011-01-14 |
| K101200 | 2010-09-30 |
| K091405 | 2009-07-29 |
| K070475 | 2007-05-07 |
| K062786 | 2006-10-18 |
| K053639 | 2006-05-08 |
| K040248 | 2004-02-17 |
| K032405 | 2003-10-29 |
| K031033 | 2003-07-01 |
| K022980 | 2003-02-27 |
| K022362 | 2002-08-09 |
| K020341 | 2002-05-02 |
| DEN010002 | 2001-08-01 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2011-03-08 | Not classified | Device Design | The capsule holder can break away from the catheter during endoscopic procedures, necessitating retrieval. | 389 | 2011-12-02 |
| 2007-12-13 | Not classified | Employee error | The cards included in the product’s education kit (proposing a clinical algorithm for capsule endoscopy in patients with suspected Crohn’s disease), were printed incorrectly. | 1392 units | 2010-11-15 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.