CapsoAccess
Model 3 · CAPSOVISION, INC. · DI 00867770000230
NEZ — System, Imaging, Gastrointestinal, Wireless, Capsule · Class II · 21 CFR 876.1300
UDILibrary device dossier · generated 2026-09-13 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.
Recall history (3)
| Initiated | Recall # | Class | Status | Reason | Link basis |
|---|---|---|---|---|---|
| 2020-02-26 | Z-2536-2020 | Class II | Terminated | 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. | k number procode |
| 2019-10-18 | Z-1827-2020 | Class II | Terminated | 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 could leak in to the capsule, which may damage components inside the capsule and the patient data may not be retrieved; the patient may need to repeat the exam. | k number procode |
| 2019-07-03 | Z-2073-2020 | Class II | Terminated | Possible mis-labeling of the device with incorrect serial number labels which may result in a patient's misdiagnosis. | k number procode |
Adverse-event reports — MAUDE (0)
Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 1.4 |
| 2019-02 | 0 | 1.29 |
| 2019-03 | 0 | 1.33 |
| 2019-04 | 0 | 2 |
| 2019-06 | 0 | 1.33 |
| 2019-07 | 0 | 1.25 |
| 2019-09 | 0 | 1 |
| 2019-10 | 0 | 1 |
| 2019-11 | 0 | 1 |
| 2019-12 | 0 | 2.5 |
| 2020-01 | 0 | 1 |
| 2020-03 | 0 | 1.67 |
| 2020-05 | 0 | 1 |
| 2020-07 | 0 | 1 |
| 2020-09 | 0 | 1 |
| 2020-10 | 0 | 1 |
| 2021-01 | 0 | 1 |
| 2021-03 | 0 | 1 |
| 2021-05 | 0 | 1 |
| 2021-06 | 0 | 2.33 |
| 2021-07 | 0 | 1.4 |
| 2021-08 | 0 | 1 |
| 2021-09 | 0 | 1 |
| 2021-10 | 0 | 1 |
| 2021-11 | 0 | 1 |
| 2022-03 | 0 | 1 |
| 2022-04 | 0 | 1.2 |
| 2022-05 | 0 | 2.5 |
| 2022-07 | 0 | 1 |
| 2022-08 | 0 | 1 |
| 2022-09 | 0 | 2 |
| 2022-10 | 0 | 2.67 |
| 2022-11 | 0 | 1 |
| 2023-01 | 0 | 1 |
| 2023-03 | 0 | 1.67 |
| 2023-04 | 0 | 1.5 |
| 2023-05 | 0 | 1 |
| 2023-06 | 0 | 1.5 |
| 2023-07 | 0 | 2 |
| 2023-09 | 0 | 1 |
| 2023-10 | 0 | 2 |
| 2023-11 | 0 | 1 |
| 2023-12 | 0 | 1 |
| 2024-02 | 0 | 1.5 |
| 2024-03 | 0 | 1 |
| 2024-04 | 0 | 2 |
| 2024-05 | 0 | 1 |
| 2024-06 | 0 | 14.5 |
| 2024-07 | 0 | 15 |
| 2024-08 | 0 | 4.33 |
| 2024-09 | 0 | 9.5 |
| 2024-10 | 0 | 3.8 |
| 2024-11 | 0 | 2.33 |
| 2024-12 | 0 | 4.67 |
| 2025-01 | 0 | 2.33 |
| 2025-02 | 0 | 2 |
| 2025-03 | 0 | 1 |
| 2025-04 | 0 | 2 |
| 2025-05 | 0 | 4.33 |
| 2025-06 | 0 | 3 |
| 2025-07 | 0 | 3.67 |
| 2025-08 | 0 | 2 |
| 2025-09 | 0 | 2 |
| 2025-10 | 0 | 3.33 |
| 2025-11 | 0 | 2.67 |
| 2025-12 | 0 | 3.25 |
| 2026-01 | 0 | 1.5 |
| 2026-02 | 0 | 1 |
| 2026-03 | 0 | 5 |
| 2026-04 | 0 | 1.25 |
| 2026-05 | 0 | 1 |
| 2026-06 | 0 | 1.33 |
Regulatory clearances
- K192662 SESE 2020-02-14 (k number procode)
- K183192 SESE 2019-04-19 (k number procode)
- K161773 SESE 2016-10-21 (k number procode)
Predicate lineage
K161773 — cites (transitively): K151635 (d1), K161535 (d1), K070475 (d2), K051663 (d2), K051942 (d2), K053276 (d2), K061342 (d2), K072605 (d2), K083089 (d2)
K183192 — cited as predicate by K192662
K192662 — cites (transitively): K183192 (d1)
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — CAPSOVISION, INC.
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