UNIVERSAL POOLE SUCTION TUBE— 510(k) K896556

Substantially Equivalent

Westmark, Sterile Packing Systems, Inc. (Sps)

FDA 510(k) clearance K896556 for UNIVERSAL POOLE SUCTION TUBE, Substantially Equivalent on 1990-02-06. Applicant: Westmark, Sterile Packing Systems, Inc. (Sps).

Clearance details

Applicant: Westmark, Sterile Packing Systems, Inc. (Sps)
Product code: Code GCX
Advisory panel: General Hospital
Date received: 1989-11-17
Decision date: 1990-02-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Grand Rapids, MI, US

Download summary PDF View on FDA.gov ↗

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.