VACUSAFE DISP. VACUUM - EXTRACTION SYSTEM— 510(k) K894695

Substantially Equivalent

Medistad Corp.

FDA 510(k) clearance K894695 for VACUSAFE DISP. VACUUM - EXTRACTION SYSTEM, Substantially Equivalent on 1990-01-22. Applicant: Medistad Corp..

Clearance details

Applicant: Medistad Corp.
Product code: Code GCX
Advisory panel: General Hospital
Date received: 1989-07-24
Decision date: 1990-01-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Wales, PA, 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.