K231996

Substantially Equivalent

Steriking® LT-Blueline Pouches with Tyvek®

Applicant: Wipak OY
Product code: FRG
Advisory panel: General Hospital
Date received: 2023-07-05
Decision date: 2023-09-07
Decision: Substantially Equivalent
Clearance type: Special
Location: Nastola, FI

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.