510(k) K140589

STERRAD CYCLESURE 24 PLUS BIOLOGICAL INDICATOR by Mesa Laboratories, Inc. — Product Code FRC

K140589 is an FDA 510(k) premarket notification submitted by Mesa Laboratories, Inc. for the device "STERRAD CYCLESURE 24 PLUS BIOLOGICAL INDICATOR". The FDA issued a decision of Substantially Equivalent on December 3, 2014. The device falls under product code FRC (Indicator, Biological Sterilization Process), a Class II device regulated under 21 CFR 880.2800. Mesa Laboratories, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 3, 2014
Date Received
March 7, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Indicator, Biological Sterilization Process
Device Class
Class II
Regulation Number
880.2800
Review Panel
HO
Submission Type