CODMAN SUCTION PATTIE— 510(k) K901937

Substantially Equivalent

Codman & Shurtleff, Inc.

FDA 510(k) clearance K901937 for CODMAN SUCTION PATTIE, Substantially Equivalent on 1990-07-16. Applicant: Codman & Shurtleff, Inc..

Clearance details

Applicant: Codman & Shurtleff, Inc.
Product code: Code GCX
Advisory panel: General Hospital
Date received: 1990-04-30
Decision date: 1990-07-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Randolph, MA, US

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Adverse events under product code GCX

product code GCX

Death: 9
Malfunction: 592
Other: 2
Total: 603

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.