MEDICAL/SURGICAL SUCTION SYSTEM— 510(k) K851384

Substantially Equivalent

Puritan Bennett Corp.

FDA 510(k) clearance K851384 for MEDICAL/SURGICAL SUCTION SYSTEM, Substantially Equivalent on 1985-05-08. Applicant: Puritan Bennett Corp..

Clearance details

Applicant: Puritan Bennett Corp.
Product code: Code GCX
Advisory panel: General Hospital
Date received: 1985-04-09
Decision date: 1985-05-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Overland Park, KS, 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.