NONPOWERED NEUROSURGICAL INSTRUMENT— 510(k) K953173

Name: FDA 510(k) clearance K953173
Creator: U.S. Food and Drug Administration
Published: 1995-10-03

Substantially Equivalent

United States Surgical, A Division of Tyco Healthc

FDA 510(k) clearance K953173 for NONPOWERED NEUROSURGICAL INSTRUMENT, Substantially Equivalent on 1995-10-03. Applicant: United States Surgical, A Division of Tyco Healthc. Device class: 2.

Clearance details

Applicant: United States Surgical, A Division of Tyco Healthc
Product code: Code GWG
Device class: Class 2
Regulation: 21 CFR 882.1480
Advisory panel: Neurology
Date received: 1995-07-07
Decision date: 1995-10-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norwalk, CT, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code GWG

product code GWG

Death: 5
Total: 5

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.