PHASEAL, SYSTEM FOR SEALED HANDLING OF CHEMOTHERAPEUTIC AGENTS— 510(k) K972527

Substantially Equivalent

Quality System Consulting

FDA 510(k) clearance K972527 for PHASEAL, SYSTEM FOR SEALED HANDLING OF CHEMOTHERAPEUTIC AGENTS, Substantially Equivalent on 1997-09-18. Applicant: Quality System Consulting.

Clearance details

Applicant: Quality System Consulting
Product code: Code FPA
Advisory panel: General Hospital
Date received: 1997-07-07
Decision date: 1997-09-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlsbad, CA, US

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Adverse events under product code FPA

product code FPA

Death: 95
Injury: 14,421
Malfunction: 125,815
Other: 30
Total: 140,361

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.