Vis-U-All Low Temperature Sterilization Pouches/Tubing, PRO-LITE Sterilization Trays— 510(k) K222440

Substantially Equivalent

Steris

FDA 510(k) clearance K222440 for Vis-U-All Low Temperature Sterilization Pouches/Tubing, PRO-LITE Sterilization Trays, Substantially Equivalent on 2022-09-09. Applicant: Steris.

Clearance details

Applicant: Steris
Product code: Code FRG
Advisory panel: General Hospital
Date received: 2022-08-12
Decision date: 2022-09-09
Decision: Substantially Equivalent
Clearance type: Special
Location: Mentor, OH, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FRG

product code FRG

Other: 3
Total: 3

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.