510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K212397Substantially Equivalent

StealthStation S8 Cranial v2.0

Medtronic Navigation, Inc, Louisville CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K212397 is the FDA 510(k) clearance record for StealthStation S8 Cranial v2.0, a class II device, cleared for Medtronic Navigation on under FDA product code HAW (Neurological Stereotaxic Instrument). FDA records list 85 510(k) clearances for Medtronic Navigation, from to . As of , FDA records show one recall naming K212397.

Clearance record

Decision date
Received
(142 days to decision)
Product code
HAW Neurological Stereotaxic Instrument
Regulation
21 CFR 882.4560
Device class
Class II
Review panel
Neurology
Applicant
Medtronic Navigation 826 Coal Creek Cir., Louisville CO
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HAW

Trailing 12 months
4 clearances under product code HAW in the twelve months to October 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code HAW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20260
May 20261
June 20260
July 20260
August 20261
September 20261
October 20260