TruDi Shaver Blade
Model TSB4STR · ACCLARENT, INC. · DI 10705031469235
ERL — Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece · Class II · 21 CFR 874.4250
PGW — Ear, Nose, And Throat Stereotaxic Instrument · Class II · 21 CFR 882.4560
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 (35)
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: 29 · Injury: 6
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 4.1 |
| 2019-02 | 0 | 3.57 |
| 2019-03 | 0 | 6.2 |
| 2019-04 | 0 | 5.17 |
| 2019-05 | 0 | 4.16 |
| 2019-06 | 0 | 4.14 |
| 2019-07 | 0 | 4.22 |
| 2019-08 | 0 | 5.34 |
| 2019-09 | 0 | 4.06 |
| 2019-10 | 0 | 4.11 |
| 2019-11 | 0 | 5.05 |
| 2019-12 | 0 | 5.06 |
| 2020-01 | 0 | 4.14 |
| 2020-02 | 0 | 3.82 |
| 2020-03 | 0 | 4.81 |
| 2020-04 | 0 | 4.42 |
| 2020-05 | 0 | 2.97 |
| 2020-06 | 0 | 5.43 |
| 2020-07 | 0 | 5.29 |
| 2020-08 | 0 | 4.58 |
| 2020-09 | 0 | 4.32 |
| 2020-10 | 0 | 5.16 |
| 2020-11 | 0 | 4.65 |
| 2020-12 | 0 | 5.08 |
| 2021-01 | 0 | 4.75 |
| 2021-02 | 0 | 5.08 |
| 2021-03 | 0 | 5.81 |
| 2021-04 | 0 | 4.61 |
| 2021-05 | 0 | 4.72 |
| 2021-06 | 0 | 5.4 |
| 2021-07 | 0 | 4.56 |
| 2021-08 | 0 | 4.92 |
| 2021-09 | 0 | 3.87 |
| 2021-10 | 0 | 3.18 |
| 2021-11 | 0 | 4.04 |
| 2021-12 | 0 | 3.67 |
| 2022-01 | 0 | 3.4 |
| 2022-02 | 0 | 3.18 |
| 2022-03 | 0 | 3.43 |
| 2022-04 | 0 | 3.71 |
| 2022-05 | 0 | 3.01 |
| 2022-06 | 0 | 4.01 |
| 2022-07 | 0 | 4.15 |
| 2022-08 | 0 | 4.22 |
| 2022-09 | 0 | 3.56 |
| 2022-10 | 0 | 4.17 |
| 2022-11 | 0 | 4.43 |
| 2022-12 | 0 | 4.13 |
| 2023-01 | 0 | 3.53 |
| 2023-02 | 0 | 3.79 |
| 2023-03 | 0 | 4.43 |
| 2023-04 | 3 | 3.95 |
| 2023-05 | 0 | 5.04 |
| 2023-06 | 3 | 3.88 |
| 2023-07 | 0 | 4.26 |
| 2023-08 | 0 | 3.73 |
| 2023-09 | 0 | 3.74 |
| 2023-10 | 2 | 3.48 |
| 2023-11 | 4 | 3.65 |
| 2023-12 | 4 | 3.43 |
| 2024-01 | 0 | 3.84 |
| 2024-02 | 0 | 4.49 |
| 2024-03 | 2 | 4.1 |
| 2024-04 | 0 | 4.23 |
| 2024-05 | 4 | 3.21 |
| 2024-06 | 2 | 3.29 |
| 2024-07 | 3 | 3.49 |
| 2024-08 | 0 | 3.73 |
| 2024-09 | 0 | 4.31 |
| 2024-10 | 0 | 4.09 |
| 2024-11 | 0 | 3.75 |
| 2024-12 | 0 | 3.48 |
| 2025-01 | 0 | 2.79 |
| 2025-02 | 4 | 6.44 |
| 2025-03 | 0 | 4.81 |
| 2025-04 | 2 | 2.87 |
| 2025-05 | 0 | 4.48 |
| 2025-06 | 0 | 3.71 |
| 2025-07 | 0 | 3.62 |
| 2025-08 | 0 | 3.52 |
| 2025-09 | 2 | 3.1 |
| 2025-10 | 0 | 3.67 |
| 2025-11 | 0 | 3.3 |
| 2025-12 | 0 | 3.28 |
| 2026-01 | 0 | 2.53 |
| 2026-02 | 0 | 3.33 |
| 2026-03 | 0 | 3.73 |
| 2026-04 | 0 | 4.7 |
| 2026-05 | 0 | 3.91 |
| 2026-06 | 0 | 4 |
Regulatory clearances
- K221037 SESE 2022-07-20 (k number procode)
Predicate lineage
K221037 — cites (transitively): K083720 (d1), K130608 (d1), K192397 (d1), K201174 (d1), K162176 (d2), K173628 (d2), K161555 (d2), K193453 (d2), K122096 (d3), K133573 (d3), K161701 (d3), K150473 (d3), K014256 (d4), K001284 (d4), K960330 (d4), K964229 (d4), K983529 (d4), K133916 (d4), K130721 (d5)
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