VS3 Iridium
Model 175-0012RFB · VISIONSENSE LTD. · DI 10884521844681
GCJ — Laparoscope, General & Plastic Surgery · Class II · 21 CFR 876.1500
GWG — Endoscope, Neurological · Class II · 21 CFR 882.1480
HRX — Arthroscope · Class II · 21 CFR 888.1100
OWN — Confocal Optical Imaging · Class II · 21 CFR 876.1500
UDILibrary device dossier · generated 2026-09-15 · 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 | 6.91 |
| 2019-02 | 0 | 3.45 |
| 2019-03 | 0 | 3.19 |
| 2019-04 | 0 | 3.47 |
| 2019-05 | 0 | 3.05 |
| 2019-06 | 0 | 3.54 |
| 2019-07 | 0 | 2.7 |
| 2019-08 | 0 | 2.97 |
| 2019-09 | 0 | 3.15 |
| 2019-10 | 0 | 3.5 |
| 2019-11 | 0 | 3.03 |
| 2019-12 | 0 | 3.18 |
| 2020-01 | 0 | 3.41 |
| 2020-02 | 0 | 3.56 |
| 2020-03 | 0 | 3.29 |
| 2020-04 | 0 | 3.35 |
| 2020-05 | 0 | 2.73 |
| 2020-06 | 0 | 3.78 |
| 2020-07 | 0 | 3.62 |
| 2020-08 | 0 | 4.69 |
| 2020-09 | 0 | 5.54 |
| 2020-10 | 0 | 5.51 |
| 2020-11 | 0 | 4.9 |
| 2020-12 | 0 | 5.64 |
| 2021-01 | 0 | 4.77 |
| 2021-02 | 0 | 4.51 |
| 2021-03 | 0 | 5.89 |
| 2021-04 | 0 | 5.26 |
| 2021-05 | 0 | 4.6 |
| 2021-06 | 0 | 4.7 |
| 2021-07 | 0 | 4.19 |
| 2021-08 | 0 | 4.2 |
| 2021-09 | 0 | 3.76 |
| 2021-10 | 0 | 4.29 |
| 2021-11 | 0 | 3.56 |
| 2021-12 | 0 | 4.77 |
| 2022-01 | 0 | 4.63 |
| 2022-02 | 0 | 4.78 |
| 2022-03 | 0 | 5.18 |
| 2022-04 | 0 | 5.65 |
| 2022-05 | 0 | 5.44 |
| 2022-06 | 0 | 5.61 |
| 2022-07 | 0 | 5.76 |
| 2022-08 | 0 | 5.6 |
| 2022-09 | 0 | 4.95 |
| 2022-10 | 0 | 4.96 |
| 2022-11 | 0 | 5.24 |
| 2022-12 | 0 | 5.58 |
| 2023-01 | 0 | 5.51 |
| 2023-02 | 0 | 4.67 |
| 2023-03 | 0 | 5.69 |
| 2023-04 | 0 | 5.35 |
| 2023-05 | 0 | 5.64 |
| 2023-06 | 0 | 6.11 |
| 2023-07 | 0 | 5.47 |
| 2023-08 | 0 | 5.99 |
| 2023-09 | 0 | 5.71 |
| 2023-10 | 0 | 5.79 |
| 2023-11 | 0 | 6.4 |
| 2023-12 | 0 | 7 |
| 2024-01 | 0 | 5.8 |
| 2024-02 | 0 | 6.62 |
| 2024-03 | 0 | 5.71 |
| 2024-04 | 0 | 6.4 |
| 2024-05 | 0 | 6.37 |
| 2024-06 | 0 | 7.88 |
| 2024-07 | 0 | 5.9 |
| 2024-08 | 0 | 6.34 |
| 2024-09 | 0 | 5.97 |
| 2024-10 | 0 | 7.03 |
| 2024-11 | 0 | 4.8 |
| 2024-12 | 0 | 5.82 |
| 2025-01 | 0 | 5.69 |
| 2025-02 | 0 | 4.6 |
| 2025-03 | 0 | 5.13 |
| 2025-04 | 0 | 4.83 |
| 2025-05 | 0 | 4.96 |
| 2025-06 | 0 | 4.69 |
| 2025-07 | 0 | 4.92 |
| 2025-08 | 0 | 5.07 |
| 2025-09 | 0 | 4.11 |
| 2025-10 | 0 | 4.61 |
| 2025-11 | 0 | 4.95 |
| 2025-12 | 0 | 5.88 |
| 2026-01 | 0 | 5.06 |
| 2026-02 | 0 | 5.03 |
| 2026-03 | 0 | 5.46 |
| 2026-04 | 0 | 6.37 |
| 2026-05 | 0 | 5.35 |
| 2026-06 | 0 | 4.81 |
Regulatory clearances
- K223020 SESE 2022-10-28 (k number procode)
Predicate lineage
K223020 — cites (transitively): K150018 (d1), K152204 (d1), K183453 (d1), K191851 (d1), K210265 (d1), K063345 (d2), K123467 (d2), K131434 (d2), K141002 (d2), K091515 (d2), K073279 (d2), K081102 (d2), K082355 (d2), K082667 (d2), K153548 (d2), K171208 (d2), K182606 (d2), K983365 (d3), K150956 (d3), K161792 (d3), K141077 (d4), K142310 (d4), K124031 (d5), K132785 (d5), K910132 (d5), K983566 (d6) — cited as predicate by K233564, K250455, K261037
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — VISIONSENSE LTD.
- VAI 2022-08-04 Visionsense, Ltd. · 1 citations