PillCam Genius
PillCam Genius SB Capsule Endoscopy Kit
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 |
| 510(k) | K240276 |
| Record published | 2024-11-29 |
| Record revised | 2025-01-15 (version 2) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
| Storage | Storage environment temperature 15 to 26 °C; Storage environment atmospheric pressure 70 to 106 KiloPascal; Storage environment humidity 30 to 70 % RH; Special storage condition: Fragile, Keep dry |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| FGS-0689 | 5 | In distribution | |
| FGS-0806 | In distribution | ||
| FGS-0688 | In distribution |
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 |
| System, Imaging, Gastrointestinal, Wireless, Capsule | 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.