neuro inspire— 510(k) K163666

Name: FDA 510(k) clearance K163666
Creator: U.S. Food and Drug Administration
Published: 2017-09-15

Substantially Equivalent

Rensihaw Plc

FDA 510(k) clearance K163666 for neuro inspire, Substantially Equivalent on 2017-09-15. Applicant: Rensihaw Plc. Device class: 2.

Clearance details

Applicant: Rensihaw Plc
Product code: Code HAW
Device class: Class 2
Regulation: 21 CFR 882.4560
Advisory panel: Neurology
Date received: 2016-12-27
Decision date: 2017-09-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wotton-Under-Edge, GB

Download summary PDF View on FDA.gov ↗

Recent devices under product code HAW

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K253856 — Geniant Cranial (Navigated Neurosurgical Positioning Robot)2026-09-10
K261932 — Leksell® Vantage Stereotactic System2026-08-05
K253663 — Zeta Navigation System2026-05-01
K253379 — Stealth AXiS Cranial clinical application2026-03-26
K231897 — NeuroAlign software2025-10-21

Adverse events under product code HAW

product code HAW

Death: 52
Injury: 1,083
Malfunction: 17,300
Total: 18,435

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.