NEURO-PATCH— 510(k) K960470

Name: FDA 510(k) clearance K960470
Creator: U.S. Food and Drug Administration
Published: 1996-05-10

Substantially Equivalent

Aesculap, Inc.

FDA 510(k) clearance K960470 for NEURO-PATCH, Substantially Equivalent on 1996-05-10. Applicant: Aesculap, Inc.. Device class: 2.

Clearance details

Applicant: Aesculap, Inc.
Product code: Code GXQ
Device class: Class 2
Regulation: 21 CFR 882.5910
Advisory panel: Neurology
Date received: 1996-02-01
Decision date: 1996-05-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South San Francisco, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code GXQ

product code GXQ

Death: 11
Injury: 446
Other: 1
Total: 458

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.