Clearance Summary
Tyvek® Pouch/Roll with STERRAD® Chemical Indicator received FDA 510(k) clearance under submission number K141693, sponsored by Advanced Sterilization Products. 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 2014-12-19.
- Submission: K141693
- Applicant / Sponsor: Advanced Sterilization Products
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.6850
- Decision date: 2014-12-19
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.