TruDi Probe
Model TDP0705Z · ACCLARENT, INC. · DI 20705031464220
PGW — Ear, Nose, And Throat Stereotaxic Instrument · Class II · 21 CFR 882.4560
UDILibrary device dossier · generated 2026-09-12 · 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 (3)
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.
Malfunction: 3
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 2.75 |
| 2019-02 | 0 | 3 |
| 2019-03 | 0 | 4.67 |
| 2019-04 | 0 | 2.44 |
| 2019-05 | 0 | 22 |
| 2019-06 | 0 | 4.25 |
| 2019-07 | 0 | 6 |
| 2019-08 | 0 | 7 |
| 2019-09 | 0 | 2.2 |
| 2019-10 | 0 | 1.75 |
| 2019-11 | 0 | 1.25 |
| 2019-12 | 0 | 5 |
| 2020-01 | 0 | 1.5 |
| 2020-02 | 0 | 2.4 |
| 2020-03 | 0 | 6 |
| 2020-04 | 0 | 1.5 |
| 2020-05 | 0 | 2 |
| 2020-06 | 0 | 2.4 |
| 2020-07 | 0 | 3 |
| 2020-08 | 0 | 5 |
| 2020-09 | 0 | 1.33 |
| 2020-10 | 0 | 6 |
| 2020-11 | 0 | 1.5 |
| 2020-12 | 0 | 5 |
| 2021-01 | 0 | 3 |
| 2021-02 | 0 | 4.5 |
| 2021-03 | 0 | 8 |
| 2021-04 | 0 | 5.33 |
| 2021-05 | 0 | 10.5 |
| 2021-06 | 0 | 5 |
| 2021-07 | 0 | 6.67 |
| 2021-08 | 0 | 5.6 |
| 2021-09 | 0 | 3.2 |
| 2021-10 | 0 | 3 |
| 2021-11 | 0 | 3 |
| 2021-12 | 0 | 3.67 |
| 2022-01 | 0 | 2.5 |
| 2022-02 | 0 | 3.75 |
| 2022-03 | 0 | 4.5 |
| 2022-04 | 0 | 3 |
| 2022-05 | 0 | 4.5 |
| 2022-06 | 0 | 2.89 |
| 2022-07 | 0 | 3.75 |
| 2022-08 | 0 | 3 |
| 2022-09 | 0 | 2.33 |
| 2022-10 | 0 | 5.5 |
| 2022-11 | 0 | 5.2 |
| 2022-12 | 0 | 2.25 |
| 2023-01 | 0 | 4.83 |
| 2023-02 | 0 | 2.67 |
| 2023-03 | 3 | 3.11 |
| 2023-04 | 0 | 3.5 |
| 2023-05 | 0 | 5.17 |
| 2023-06 | 0 | 3 |
| 2023-07 | 0 | 3.5 |
| 2023-08 | 0 | 3.8 |
| 2023-09 | 0 | 2.89 |
| 2023-10 | 0 | 2.5 |
| 2023-11 | 0 | 2.89 |
| 2023-12 | 0 | 4.11 |
| 2024-01 | 0 | 2 |
| 2024-02 | 0 | 3.25 |
| 2024-03 | 0 | 2.7 |
| 2024-04 | 0 | 4.09 |
| 2024-05 | 0 | 2.73 |
| 2024-06 | 0 | 2.33 |
| 2024-07 | 0 | 3 |
| 2024-08 | 0 | 6.67 |
| 2024-09 | 0 | 2 |
| 2024-10 | 0 | 4.6 |
| 2024-11 | 0 | 4.83 |
| 2024-12 | 0 | 3.8 |
| 2025-01 | 0 | 1.92 |
| 2025-02 | 0 | 4.65 |
| 2025-03 | 0 | 3.43 |
| 2025-04 | 0 | 1.93 |
| 2025-05 | 0 | 5.67 |
| 2025-06 | 0 | 8.5 |
| 2025-07 | 0 | 1.75 |
| 2025-08 | 0 | 4 |
| 2025-09 | 0 | 3 |
| 2025-10 | 0 | 2.4 |
| 2025-11 | 0 | 4.5 |
| 2025-12 | 0 | 2 |
| 2026-01 | 0 | 2.1 |
| 2026-02 | 0 | 2.33 |
| 2026-03 | 0 | 6.5 |
| 2026-04 | 0 | 1.38 |
| 2026-05 | 0 | 3 |
| 2026-06 | 0 | 2 |
Regulatory clearances
- K193453 SESE 2020-03-23 (k number procode)
Predicate lineage
K193453 — cites (transitively): K150473 (d1), K192397 (d1), K133573 (d2), K162176 (d2), K173628 (d2), K001284 (d3), K960330 (d3), K964229 (d3), K983529 (d3), K161701 (d3), K133916 (d4), K130721 (d5) — cited as predicate by K201174
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — ACCLARENT, INC.
- Warning Letter 2013-03-20 Acclarent, Inc.
- Warning Letter 2013-03-20 Acclarent, Inc.
- Warning Letter 2012-06-14 Acclarent, Inc.
- Warning Letter 2012-06-14 Acclarent, Inc.
- NAI 2020-09-25 Acclarent, Inc. · 0 citations
- NAI 2020-09-25 Acclarent, Inc. · 0 citations
- VAI 2013-12-09 Acclarent, Inc. · 0 citations
- VAI 2013-12-09 Acclarent, Inc. · 0 citations
- OAI 2013-02-22 Acclarent, Inc. · 2 citations
- OAI 2013-02-22 Acclarent, Inc. · 2 citations
- OAI 2012-02-24 Acclarent, Inc. · 3 citations
- OAI 2012-02-24 Acclarent, Inc. · 3 citations