CODMAN CRANIOTOMY KIT, MODELS 26-1229, 26-1230, 26-1231— 510(k) K073336

Substantially Equivalent

Codman & Shurtleff, Inc.

FDA 510(k) clearance K073336 for CODMAN CRANIOTOMY KIT, MODELS 26-1229, 26-1230, 26-1231, Substantially Equivalent on 2008-01-04. Applicant: Codman & Shurtleff, Inc..

Clearance details

Applicant: Codman & Shurtleff, Inc.
Product code: Code HBF
Advisory panel: Neurology
Date received: 2007-11-28
Decision date: 2008-01-04
Decision: Substantially Equivalent
Clearance type: Special
Location: Raynham, MA, US

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Adverse events under product code HBF

product code HBF

Injury: 587
Malfunction: 621
Other: 1
Total: 1,209

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.