STAT IM 5000 CASSETTE AUTOCLAVE— 510(k) K962179

Substantially Equivalent

Scican

FDA 510(k) clearance K962179 for STAT IM 5000 CASSETTE AUTOCLAVE, Substantially Equivalent on 1997-01-13. Applicant: Scican.

Clearance details

Applicant: Scican
Product code: Code FLE
Advisory panel: General Hospital
Date received: 1996-06-06
Decision date: 1997-01-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pittsburgh, PA, US

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Adverse events under product code FLE

product code FLE

Malfunction: 444
Total: 444

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.