STEAM VACUUM PULSE STERILIZER SYSTEM (SVPSS)— 510(k) K910778

Substantially Equivalent

Mdt Biologic Co.

FDA 510(k) clearance K910778 for STEAM VACUUM PULSE STERILIZER SYSTEM (SVPSS), Substantially Equivalent on 1991-10-28. Applicant: Mdt Biologic Co..

Clearance details

Applicant: Mdt Biologic Co.
Product code: Code FLE
Advisory panel: General Hospital
Date received: 1991-02-22
Decision date: 1991-10-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rochester, NY, US

Download summary PDF View on FDA.gov ↗

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.