KELLY-GROERSS-KALL CT STEROTACTIC ADAPTATION SYS— 510(k) K852477

Name: FDA 510(k) clearance K852477
Creator: U.S. Food and Drug Administration
Published: 1985-07-30

Substantially Equivalent

Mayo Clinic

FDA 510(k) clearance K852477 for KELLY-GROERSS-KALL CT STEROTACTIC ADAPTATION SYS, Substantially Equivalent on 1985-07-30. Applicant: Mayo Clinic. Device class: 2.

Clearance details

Applicant: Mayo Clinic
Product code: Code HAW
Device class: Class 2
Regulation: 21 CFR 882.4560
Advisory panel: Neurology
Date received: 1985-06-11
Decision date: 1985-07-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rochester, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HAW

view all

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 Mayo Clinic

view all

K040122 — MAYO CLINIC BC-10 3.0T2004-04-14
K943230 — MAYO HIP PROSTHESIS1997-01-14

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.