Steriking® LT-Blueline Pouches with Tyvek®— 510(k) K231999

Substantially Equivalent

Wipak OY

FDA 510(k) clearance K231999 for Steriking® LT-Blueline Pouches with Tyvek®, Substantially Equivalent on 2023-09-07. Applicant: Wipak OY.

Clearance details

Applicant: Wipak OY
Product code: 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

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.