SteriKing LT-Blueline Pouches with Tyvek— 510(k) K221377

Substantially Equivalent

Wipak OY

FDA 510(k) clearance K221377 for SteriKing LT-Blueline Pouches with Tyvek, Substantially Equivalent on 2022-12-22. Applicant: Wipak OY.

Clearance details

Applicant: Wipak OY
Product code: Code FRG
Advisory panel: General Hospital
Date received: 2022-05-12
Decision date: 2022-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nastola, FI

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.