CapsoAccess
Capsule Data Access System
1manufacturer
1catalogue number
6510(k) clearances naming this product code
3recalls 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 | CapsoVision, Inc., United States |
|---|---|
| FDA product code | NEZ |
| Device type | System, Imaging, Gastrointestinal, Wireless, Capsule |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1300 |
| Establishment | Manufacturer |
| 510(k) | K161773 |
| Record published | 2018-07-17 |
| Record revised | 2020-12-10 (version 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Storage | Handling environment atmospheric pressure 19 to 101 KiloPascal; Handling environment humidity 10 to 90 % RH; Handling environment temperature 10 to 35 °C; Storage environment atmospheric pressure 19 to 101 KiloPascal; Storage environment humidity 10 to 90 % RH; Storage environment temperature 10 to 35 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 3 | 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 |
| 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 |
Showing 12 of 44. All products under System, Imaging, Gastrointestinal, Wireless, Capsule
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K252480 | 2025-12-19 |
| K242643 | 2024-12-04 |
| K192662 | 2020-02-14 |
| K183192 | 2019-04-19 |
| K161773 | 2016-10-21 |
| K151635 | 2016-02-09 |
Recalls Naming This Product
3 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| CapsoVision, Inc. | 510(k) number | 2020-02-26 | Class II | Employee error | Ingestible video capsule system has capsule with incorrect capture mode which will not record data when the capsule is ingested by patients. If used, there is a risk of delay of diagnosis and the patient may need to repeat the exam. | 82 | 2021-01-28 |
| CapsoVision, Inc. | 510(k) number | 2019-10-18 | Class II | Other | Capsule Endoscopy System: a defect present in the capsule window may be stressed through the production process and in the final package, which could cause the housing of the capsule to crack and leak when ingested. Fluid from the patient c | 1882 | 2021-01-08 |
| CapsoVision, Inc. | 510(k) number | 2019-07-03 | Class II | Process control | Possible mis-labeling of the device with incorrect serial number labels which may result in a patient’s misdiagnosis. | 44 units | 2021-01-28 |
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.