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21001 PercuNav Endocavity Ultrasound Tracker
Model 989605435122 · Philips Ultrasound LLC · DI 00884838068636
ITX — Transducer, Ultrasonic, Diagnostic · Class II · 21 CFR 892.1570
IYN — System, Imaging, Pulsed Doppler, Ultrasonic · Class II · 21 CFR 892.1550
IYO — System, Imaging, Pulsed Echo, Ultrasonic · Class II · 21 CFR 892.1560
JAK — System, X-Ray, Tomography, Computed · Class II · 21 CFR 892.1750
UDILibrary device dossier · generated 2026-09-07 · 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.
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-01
0
3.48
2019-02
0
5.02
2019-03
0
5.03
2019-04
0
3.95
2019-05
0
4.84
2019-06
0
5.66
2019-07
0
4.8
2019-08
0
6.76
2019-09
0
3.72
2019-10
0
3.35
2019-11
0
3.79
2019-12
0
4.93
2020-01
0
2.64
2020-02
0
4.68
2020-03
0
5.21
2020-04
0
5.09
2020-05
0
2.77
2020-06
0
3.07
2020-07
0
3.95
2020-08
0
2.7
2020-09
0
2.05
2020-10
0
3.42
2020-11
0
3.7
2020-12
0
5.43
2021-01
0
5.79
2021-02
0
4.09
2021-03
0
6.37
2021-04
0
3.86
2021-05
0
5.54
2021-06
0
6.06
2021-07
0
7.53
2021-08
0
6.4
2021-09
0
7.47
2021-10
0
5.11
2021-11
0
6.04
2021-12
0
8.16
2022-01
0
5.57
2022-02
0
6.95
2022-03
0
6.26
2022-04
0
7.21
2022-05
0
8.85
2022-06
0
6.09
2022-07
0
6.6
2022-08
0
4.57
2022-09
0
4.24
2022-10
0
4.34
2022-11
0
4.04
2022-12
0
4.51
2023-01
0
4.63
2023-02
0
4.19
2023-03
0
5.15
2023-04
0
3.62
2023-05
0
5.22
2023-06
0
4.65
2023-07
0
3.85
2023-08
0
5.21
2023-09
0
5.09
2023-10
0
6.53
2023-11
0
4.86
2023-12
0
4.92
2024-01
0
5.72
2024-02
0
3.95
2024-03
0
5.14
2024-04
0
5.06
2024-05
0
3.82
2024-06
0
5.52
2024-07
0
4.53
2024-08
0
5.01
2024-09
0
5.32
2024-10
0
5.66
2024-11
0
3.63
2024-12
0
10
2025-01
0
3.95
2025-02
0
3.71
2025-03
0
5
2025-04
0
3.1
2025-05
0
3.85
2025-06
0
3.89
2025-07
0
3.88
2025-08
0
5.04
2025-09
0
6.09
2025-10
0
9.13
2025-11
0
11.36
2025-12
0
17.38
2026-01
0
11.49
2026-02
0
6.09
2026-03
0
8.17
2026-04
0
10.78
2026-05
0
15.32
2026-06
0
12.84
This device (reports/month)Average device in ITX, IYN, IYO, JAK (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — Philips Ultrasound LLC