CODMAN DISPOSABLE PLASTIC INTRACRANIAL PRESS/KIT— 510(k) K853770

Substantially Equivalent

Codman & Shurtleff, Inc.

FDA 510(k) clearance K853770 for CODMAN DISPOSABLE PLASTIC INTRACRANIAL PRESS/KIT, Substantially Equivalent on 1986-10-06. Applicant: Codman & Shurtleff, Inc..

Clearance details

Applicant: Codman & Shurtleff, Inc.
Product code: Code GWM
Advisory panel: Neurology
Date received: 1985-09-09
Decision date: 1986-10-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Randolph, MA, US

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Adverse events under product code GWM

product code GWM

Death: 21
Injury: 732
Malfunction: 2,063
Other: 1
Total: 2,817

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.