PINPOINT PAQ
Model PP9031 · Novadaq Technologies Inc · DI 10858701006176
GCJ — Laparoscope, General & Plastic Surgery · Class II · 21 CFR 876.1500
IZI — System, X-Ray, Angiographic · Class II · 21 CFR 892.1600
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 | 2.56 |
| 2019-02 | 0 | 3.56 |
| 2019-03 | 0 | 3.06 |
| 2019-04 | 0 | 3.9 |
| 2019-05 | 0 | 2.56 |
| 2019-06 | 0 | 3.54 |
| 2019-07 | 0 | 2.48 |
| 2019-08 | 0 | 2.46 |
| 2019-09 | 0 | 2.49 |
| 2019-10 | 0 | 2.72 |
| 2019-11 | 0 | 2.1 |
| 2019-12 | 0 | 2.41 |
| 2020-01 | 0 | 2.55 |
| 2020-02 | 0 | 2.75 |
| 2020-03 | 0 | 2.27 |
| 2020-04 | 0 | 2.54 |
| 2020-05 | 0 | 1.98 |
| 2020-06 | 0 | 2.78 |
| 2020-07 | 0 | 2.72 |
| 2020-08 | 0 | 4.17 |
| 2020-09 | 0 | 4.29 |
| 2020-10 | 0 | 3.82 |
| 2020-11 | 0 | 4.24 |
| 2020-12 | 0 | 3.72 |
| 2021-01 | 0 | 3.79 |
| 2021-02 | 0 | 3.68 |
| 2021-03 | 0 | 4.65 |
| 2021-04 | 0 | 4.72 |
| 2021-05 | 0 | 4.13 |
| 2021-06 | 0 | 4.47 |
| 2021-07 | 0 | 3.86 |
| 2021-08 | 0 | 3.86 |
| 2021-09 | 0 | 4 |
| 2021-10 | 0 | 3.83 |
| 2021-11 | 0 | 3.49 |
| 2021-12 | 0 | 4.44 |
| 2022-01 | 0 | 4.35 |
| 2022-02 | 0 | 4.78 |
| 2022-03 | 0 | 5.3 |
| 2022-04 | 0 | 6.27 |
| 2022-05 | 0 | 5.36 |
| 2022-06 | 0 | 6.05 |
| 2022-07 | 0 | 6.08 |
| 2022-08 | 0 | 6.14 |
| 2022-09 | 0 | 5.43 |
| 2022-10 | 0 | 7.22 |
| 2022-11 | 0 | 11.5 |
| 2022-12 | 0 | 11.34 |
| 2023-01 | 0 | 11.57 |
| 2023-02 | 0 | 8.73 |
| 2023-03 | 0 | 14.92 |
| 2023-04 | 0 | 9.63 |
| 2023-05 | 0 | 11.2 |
| 2023-06 | 0 | 11.52 |
| 2023-07 | 0 | 9.29 |
| 2023-08 | 0 | 9.63 |
| 2023-09 | 0 | 10.8 |
| 2023-10 | 0 | 10.57 |
| 2023-11 | 0 | 10.78 |
| 2023-12 | 0 | 10.66 |
| 2024-01 | 0 | 10.42 |
| 2024-02 | 0 | 13.34 |
| 2024-03 | 0 | 10.04 |
| 2024-04 | 0 | 10.04 |
| 2024-05 | 0 | 8.44 |
| 2024-06 | 0 | 10.62 |
| 2024-07 | 0 | 9.87 |
| 2024-08 | 0 | 11.19 |
| 2024-09 | 0 | 10.77 |
| 2024-10 | 0 | 11.61 |
| 2024-11 | 0 | 8.44 |
| 2024-12 | 0 | 8.67 |
| 2025-01 | 0 | 8.01 |
| 2025-02 | 0 | 11.11 |
| 2025-03 | 0 | 9.2 |
| 2025-04 | 0 | 11.31 |
| 2025-05 | 0 | 10.41 |
| 2025-06 | 0 | 12.08 |
| 2025-07 | 0 | 11.95 |
| 2025-08 | 0 | 20.16 |
| 2025-09 | 0 | 25.25 |
| 2025-10 | 0 | 28.04 |
| 2025-11 | 0 | 19.91 |
| 2025-12 | 0 | 8.35 |
| 2026-01 | 0 | 7.4 |
| 2026-02 | 0 | 6.83 |
| 2026-03 | 0 | 7.49 |
| 2026-04 | 0 | 7.54 |
| 2026-05 | 0 | 7.51 |
| 2026-06 | 0 | 6.82 |
Regulatory clearances
- K182606 SESE 2018-11-21 (k number procode)
Predicate lineage
K182606 — cites (transitively): K150956 (d1), K161792 (d1), K091515 (d2), K141077 (d2), K142310 (d2), K124031 (d3), K132785 (d3), K910132 (d3), K983566 (d4) — cited as predicate by K191851, K192292, K200737, K202925, K212808, K213710, K221252, K221861, K223759, K231854, K233840, K260318
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — Novadaq Technologies Inc
- VAI 2011-06-30 Novadaq Technologies, Inc. · 8 citations