CODMAN SKULL CLAMP— 510(k) K912011

Substantially Equivalent

Codman & Shurtleff, Inc.

FDA 510(k) clearance K912011 for CODMAN SKULL CLAMP, Substantially Equivalent on 1991-07-31. Applicant: Codman & Shurtleff, Inc..

Clearance details

Applicant: Codman & Shurtleff, Inc.
Product code: Code HBL
Advisory panel: Neurology
Date received: 1991-05-06
Decision date: 1991-07-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Randolph, MA, US

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Adverse events under product code HBL

product code HBL

Death: 3
Injury: 753
Malfunction: 1,421
Total: 2,177

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.