510(k) K172749

Vis-U-All Low Temperature Sterilization Pouch/Tubing by STERIS Corporation — Product Code FRG

K172749 is an FDA 510(k) premarket notification submitted by STERIS Corporation for the device "Vis-U-All Low Temperature Sterilization Pouch/Tubing". The FDA issued a decision of Substantially Equivalent on Feb 9, 2018. The device falls under product code FRG (Wrap, Sterilization), a Class II device regulated under 21 CFR 880.6850. STERIS Corporation has 204 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Feb 9, 2018
Date Received
Sep 12, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wrap, Sterilization
Device Class
Class II
Regulation Number
880.6850
Review Panel
HO
Submission Type
510(k)