510(k) K151971
K151971 is an FDA 510(k) premarket notification submitted by Advanced Sterilization Products for the device "STERRAD CYCLESURE 24 Biological Indicator". The FDA issued a decision of Substantially Equivalent on October 29, 2015. The device falls under product code FRC (Indicator, Biological Sterilization Process), a Class II device regulated under 21 CFR 880.2800. Advanced Sterilization Products has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 29, 2015
- Date Received
- July 16, 2015
- 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