Wipak OY FDA Approvals

0 new drug approvals and 7 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
Steriking® Pouch for Robotic Instruments510(k)Jun 7, 2024General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Jun 7, 2024
Steriking® LT-Blueline Pouches with Tyvek®510(k)Sep 7, 2023General Hospital	General Hospital	510(k)Substantially Equivalent (Special)	Sep 7, 2023
Steriking® LT-Blueline Pouches with Tyvek®510(k)Sep 7, 2023General Hospital	General Hospital	510(k)Substantially Equivalent (Special)	Sep 7, 2023
Steriking LT-Blueline Pouches with Tyvek510(k)Jan 4, 2023General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Jan 4, 2023
SteriKing LT-Blueline Pouches with Tyvek510(k)Dec 22, 2022General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Dec 22, 2022
Steriking Packaging for Medical Devices510(k)May 5, 2022General Hospital	General Hospital	510(k)Substantially Equivalent (Special)	May 5, 2022
Steiking Packaging for Medical Devices510(k)Jan 23, 2022General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Jan 23, 2022