Indigo™
Model 31131583 · MEDTRONIC POWERED SURGICAL SOLUTIONS · DI 00643169579224
ERL — Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece · Class II · 21 CFR 874.4250
HBE — Drills, Burrs, Trephines & Accessories (Simple, Powered) · Class II · 21 CFR 882.4310
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.
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 3.34 |
| 2019-02 | 0 | 3.6 |
| 2019-03 | 0 | 5.97 |
| 2019-04 | 0 | 4.57 |
| 2019-05 | 0 | 3.94 |
| 2019-06 | 0 | 4 |
| 2019-07 | 0 | 3.76 |
| 2019-08 | 0 | 4.9 |
| 2019-09 | 0 | 3.83 |
| 2019-10 | 0 | 3.71 |
| 2019-11 | 0 | 4.67 |
| 2019-12 | 0 | 4.64 |
| 2020-01 | 0 | 3.83 |
| 2020-02 | 0 | 4.54 |
| 2020-03 | 0 | 4.85 |
| 2020-04 | 0 | 3.92 |
| 2020-05 | 0 | 2.96 |
| 2020-06 | 0 | 5.26 |
| 2020-07 | 0 | 4.67 |
| 2020-08 | 0 | 4.06 |
| 2020-09 | 0 | 4.47 |
| 2020-10 | 0 | 4.6 |
| 2020-11 | 0 | 4.72 |
| 2020-12 | 0 | 4.89 |
| 2021-01 | 0 | 4.21 |
| 2021-02 | 0 | 4.41 |
| 2021-03 | 0 | 5.01 |
| 2021-04 | 0 | 3.83 |
| 2021-05 | 0 | 3.99 |
| 2021-06 | 0 | 4.87 |
| 2021-07 | 0 | 3.99 |
| 2021-08 | 0 | 4.88 |
| 2021-09 | 0 | 3.81 |
| 2021-10 | 0 | 3.04 |
| 2021-11 | 0 | 3.93 |
| 2021-12 | 0 | 3.82 |
| 2022-01 | 0 | 3.19 |
| 2022-02 | 0 | 3.29 |
| 2022-03 | 0 | 3.54 |
| 2022-04 | 0 | 3.15 |
| 2022-05 | 0 | 3.1 |
| 2022-06 | 0 | 4.06 |
| 2022-07 | 0 | 3.64 |
| 2022-08 | 0 | 4.14 |
| 2022-09 | 0 | 3.81 |
| 2022-10 | 0 | 3.79 |
| 2022-11 | 0 | 4.07 |
| 2022-12 | 0 | 4.35 |
| 2023-01 | 0 | 3.33 |
| 2023-02 | 0 | 3.91 |
| 2023-03 | 0 | 4.41 |
| 2023-04 | 0 | 3.65 |
| 2023-05 | 0 | 4.93 |
| 2023-06 | 0 | 4 |
| 2023-07 | 0 | 3.65 |
| 2023-08 | 0 | 3.67 |
| 2023-09 | 0 | 3.78 |
| 2023-10 | 0 | 3.13 |
| 2023-11 | 0 | 3.94 |
| 2023-12 | 0 | 3.18 |
| 2024-01 | 0 | 3.62 |
| 2024-02 | 0 | 4.14 |
| 2024-03 | 0 | 4.09 |
| 2024-04 | 0 | 3.51 |
| 2024-05 | 0 | 3.11 |
| 2024-06 | 0 | 3.4 |
| 2024-07 | 0 | 3.07 |
| 2024-08 | 0 | 3.23 |
| 2024-09 | 0 | 4.19 |
| 2024-10 | 0 | 3.31 |
| 2024-11 | 0 | 3.03 |
| 2024-12 | 0 | 3.42 |
| 2025-01 | 0 | 2.74 |
| 2025-02 | 0 | 5.67 |
| 2025-03 | 0 | 3.6 |
| 2025-04 | 0 | 2.32 |
| 2025-05 | 0 | 3.45 |
| 2025-06 | 0 | 3.14 |
| 2025-07 | 0 | 3.12 |
| 2025-08 | 0 | 2.8 |
| 2025-09 | 0 | 2.62 |
| 2025-10 | 0 | 3.19 |
| 2025-11 | 0 | 3.2 |
| 2025-12 | 0 | 3.24 |
| 2026-01 | 0 | 2.26 |
| 2026-02 | 0 | 2.98 |
| 2026-03 | 0 | 4.02 |
| 2026-04 | 0 | 4.65 |
| 2026-05 | 0 | 4.51 |
| 2026-06 | 0 | 12.17 |
Regulatory clearances
- None linked in the loaded window.
Predicate lineage
K111520 — cites (transitively): K061113 (d1), K061639 (d1), K063305 (d1), K081475 (d1) — cited as predicate by K143019, K153442, K153463, K161210, K170679, K173338, K181111, K182121, K182436, K201407, K203291, K210637, K211596, K214011, K231184
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — MEDTRONIC POWERED SURGICAL SOLUTIONS
- NAI 2024-12-05 Medtronic Powered Surgical Solutions · 0 citations