VS3-IR
Model 153-0055 · VISIONSENSE LTD. · DI 10884521816701
GCJ — Laparoscope, General & Plastic Surgery · Class II · 21 CFR 876.1500
OWN — Confocal Optical Imaging · Class II · 21 CFR 876.1500
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 (0)
No recalls linked in the loaded window.
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 | 2.37 |
| 2019-02 | 0 | 3.53 |
| 2019-03 | 0 | 2.91 |
| 2019-04 | 0 | 3.11 |
| 2019-05 | 0 | 2.46 |
| 2019-06 | 0 | 3.52 |
| 2019-07 | 0 | 2.37 |
| 2019-08 | 0 | 2.43 |
| 2019-09 | 0 | 2.42 |
| 2019-10 | 0 | 2.71 |
| 2019-11 | 0 | 2.13 |
| 2019-12 | 0 | 2.4 |
| 2020-01 | 0 | 2.52 |
| 2020-02 | 0 | 2.7 |
| 2020-03 | 0 | 2.26 |
| 2020-04 | 0 | 2.52 |
| 2020-05 | 0 | 1.96 |
| 2020-06 | 0 | 2.84 |
| 2020-07 | 0 | 2.74 |
| 2020-08 | 0 | 4.22 |
| 2020-09 | 0 | 4.32 |
| 2020-10 | 0 | 3.97 |
| 2020-11 | 0 | 4.29 |
| 2020-12 | 0 | 3.78 |
| 2021-01 | 0 | 3.96 |
| 2021-02 | 0 | 3.79 |
| 2021-03 | 0 | 4.75 |
| 2021-04 | 0 | 4.73 |
| 2021-05 | 0 | 3.98 |
| 2021-06 | 0 | 4.19 |
| 2021-07 | 0 | 3.84 |
| 2021-08 | 0 | 3.83 |
| 2021-09 | 0 | 3.92 |
| 2021-10 | 0 | 3.94 |
| 2021-11 | 0 | 3.48 |
| 2021-12 | 0 | 4.55 |
| 2022-01 | 0 | 4.52 |
| 2022-02 | 0 | 5.16 |
| 2022-03 | 0 | 5.51 |
| 2022-04 | 0 | 6.44 |
| 2022-05 | 0 | 5.94 |
| 2022-06 | 0 | 6.32 |
| 2022-07 | 0 | 6.29 |
| 2022-08 | 0 | 6.2 |
| 2022-09 | 0 | 5.39 |
| 2022-10 | 0 | 5.3 |
| 2022-11 | 0 | 5.55 |
| 2022-12 | 0 | 5.93 |
| 2023-01 | 0 | 5.7 |
| 2023-02 | 0 | 4.86 |
| 2023-03 | 0 | 5.9 |
| 2023-04 | 0 | 5.56 |
| 2023-05 | 0 | 5.95 |
| 2023-06 | 0 | 6.93 |
| 2023-07 | 0 | 6.14 |
| 2023-08 | 0 | 6.36 |
| 2023-09 | 0 | 6.13 |
| 2023-10 | 0 | 6.45 |
| 2023-11 | 0 | 5.89 |
| 2023-12 | 0 | 6.2 |
| 2024-01 | 0 | 5.72 |
| 2024-02 | 0 | 6.66 |
| 2024-03 | 0 | 5.94 |
| 2024-04 | 0 | 6.62 |
| 2024-05 | 0 | 5.57 |
| 2024-06 | 0 | 7.55 |
| 2024-07 | 0 | 6.3 |
| 2024-08 | 0 | 6.89 |
| 2024-09 | 0 | 6.6 |
| 2024-10 | 0 | 7.42 |
| 2024-11 | 0 | 4.65 |
| 2024-12 | 0 | 5.01 |
| 2025-01 | 0 | 4.59 |
| 2025-02 | 0 | 4.01 |
| 2025-03 | 0 | 5.19 |
| 2025-04 | 0 | 4.64 |
| 2025-05 | 0 | 4.67 |
| 2025-06 | 0 | 4.6 |
| 2025-07 | 0 | 4.8 |
| 2025-08 | 0 | 5.4 |
| 2025-09 | 0 | 3.97 |
| 2025-10 | 0 | 4.55 |
| 2025-11 | 0 | 4.75 |
| 2025-12 | 0 | 6.03 |
| 2026-01 | 0 | 4.94 |
| 2026-02 | 0 | 4.9 |
| 2026-03 | 0 | 5.59 |
| 2026-04 | 0 | 6.2 |
| 2026-05 | 0 | 5.7 |
| 2026-06 | 0 | 4.9 |
Regulatory clearances
- K191851 SESE 2019-11-25 (k number procode)
Predicate lineage
K191851 — cites (transitively): K073279 (d1), K081102 (d1), K082355 (d1), K082667 (d1), K123467 (d1), K131434 (d1), K141002 (d1), K150018 (d1), K152204 (d1), K153548 (d1), K171208 (d1), K182606 (d1), K183453 (d1), K063345 (d2), K091515 (d2), K983365 (d2), K150956 (d2), K161792 (d2), K141077 (d3), K142310 (d3), K124031 (d4), K132785 (d4), K910132 (d4), K983566 (d5) — cited as predicate by K210265, K223020
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — VISIONSENSE LTD.
- VAI 2022-08-04 Visionsense, Ltd. · 1 citations