DeviceClearance

Stealth Autoguide System, Midas Rex Legend Depth Stop System— 510(k) K191597

Substantially Equivalent

Medtronic Navigation, Inc.

FDA 510(k) clearance K191597 for Stealth Autoguide System, Midas Rex Legend Depth Stop System, Substantially Equivalent on 2019-11-01. Applicant: Medtronic Navigation, Inc.. Device class: 2.

Clearance details

Applicant
Medtronic Navigation, Inc.
Product code
Code HAW
Device class
Class 2
Regulation
21 CFR 882.4560
Advisory panel
Neurology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Louisville, CO, US
Download summary PDFView on FDA.gov ↗

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More clearances from Medtronic Navigation, Inc.

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Adverse events under product code HAW

product code HAW
Death
52
Injury
1,083
Malfunction
17,300
Total
18,435

Source: openFDA MAUDE database, through . 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 K191597

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K191597.

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