Clearance Summary
SteriKing LT-Blueline Pouches with Tyvek received FDA 510(k) clearance under submission number K221377, sponsored by Wipak OY. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2022-12-22.
- Submission: K221377
- Applicant / Sponsor: Wipak OY
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.6850
- Decision date: 2022-12-22
Classification & Regulation
This clearance is catalogued under FDA product code FRG and 21 CFR 880.6850, within the General Hospital review panel as a Class II device.