DeviceClearance

KARL STORZ NAV1 Electromagnetic Navigation System— 510(k) K161555

Substantially Equivalent

Karl Storz Endoscopy America, Inc.

FDA 510(k) clearance K161555 for KARL STORZ NAV1 Electromagnetic Navigation System, Substantially Equivalent on 2016-10-21. Applicant: Karl Storz Endoscopy America, Inc.. Device class: 2.

Clearance details

Applicant
Karl Storz Endoscopy America, Inc.
Product code
Code PGW
Device class
Class 2
Regulation
21 CFR 882.4560
Advisory panel
Neurology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
El Segundo, CA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code PGW

product code PGW
Malfunction
1,199
Total
1,199

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 →

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