DELTAMAXX 18 MICROCOIL SYSTEM— 510(k) K120274

Name: FDA 510(k) clearance K120274
Creator: U.S. Food and Drug Administration
Published: 2012-03-02

Substantially Equivalent

Codman and Shurtleff, Inc.

FDA 510(k) clearance K120274 for DELTAMAXX 18 MICROCOIL SYSTEM, Substantially Equivalent on 2012-03-02. Applicant: Codman and Shurtleff, Inc.. Device class: 2.

Clearance details

Applicant: Codman and Shurtleff, Inc.
Product code: Code HCG
Device class: Class 2
Regulation: 21 CFR 882.5950
Advisory panel: Neurology
Date received: 2012-01-30
Decision date: 2012-03-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Raynham, MA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code HCG

product code HCG

Death: 50
Injury: 801
Malfunction: 5,625
Total: 6,476

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.