Vis-U-All Low Temperature Sterilization Pouch/Tubing— 510(k) K183297

Name: FDA 510(k) clearance K183297
Creator: U.S. Food and Drug Administration
Published: 2019-01-03

Substantially Equivalent

STERIS Corporation

FDA 510(k) clearance K183297 for Vis-U-All Low Temperature Sterilization Pouch/Tubing, Substantially Equivalent on 2019-01-03. Applicant: STERIS Corporation. Device class: 2.

Clearance details

Applicant: STERIS Corporation
Product code: Code FRG
Device class: Class 2
Regulation: 21 CFR 880.6850
Advisory panel: General Hospital
Date received: 2018-11-27
Decision date: 2019-01-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mentor, OH, US

Download summary PDF View on FDA.gov ↗

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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.