STEALTHSTATION PASSIVE INSTRUMENT OPTION— 510(k) K972398

Name: FDA 510(k) clearance K972398
Creator: U.S. Food and Drug Administration
Published: 1997-09-16

Substantially Equivalent

Surgical Navigation Technologies, Inc.

FDA 510(k) clearance K972398 for STEALTHSTATION PASSIVE INSTRUMENT OPTION, Substantially Equivalent on 1997-09-16. Applicant: Surgical Navigation Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Surgical Navigation Technologies, Inc.
Product code: Code HAW
Device class: Class 2
Regulation: 21 CFR 882.4560
Advisory panel: Neurology
Date received: 1997-06-26
Decision date: 1997-09-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Broomfield, CO, US

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

More clearances from Surgical Navigation Technologies, Inc.

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K000246 — RADIOCAMERAS EXTRACRANIAL SYSTEM2000-10-20
K994355 — RADIOCAMERAS SYSTEM HEAD/NECK APPLICATION2000-03-22
K992461 — STEALTHSTATION TREATMENT GUIDANCE PLATFORM2000-02-22
K992927 — STEALTHSTATION TREATMENT GUIDANCE PLATFORM1999-12-29
K993021 — METRX SYSTEM1999-11-10

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 →

Recalls naming K972398

K-number listed on FDA's recall record

Z-1794-2015 — Medtronic Passive Planar Blunt Probe Part Number 960-556, also included in Part Number Kits: 9732540, 9732622, 9733174, 9733935. As part of kits, the product is either packaged with other instruments or into a holding tray. The Passive Planar Blunt Probe is an optically tracked, reusable instrument used in navigated surgery and is included with Medtronic cranial instrument kits. It is designed for use in patient registration and palpating brain tissue during surgical procedures.Class II·Terminated·Medtronic Navigation, Inc.·20150505

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K972398.

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