CAROLINE GUIDE— 510(k) K981809

Substantially Equivalent

Surgical Solutions, Inc.

FDA 510(k) clearance K981809 for CAROLINE GUIDE, Substantially Equivalent on 1998-08-14. Applicant: Surgical Solutions, Inc..

Clearance details

Applicant: Surgical Solutions, Inc.
Product code: Code HAW
Advisory panel: Neurology
Date received: 1998-05-21
Decision date: 1998-08-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Iowa City, IA, US

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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, 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.