FDA 510(k)

STERRAD (R) CYCLESURE (R) 24 BIOLOGICAL INDICATOR

K-Number: K111375 · 2012-09-14

ApplicantAdvanced Sterilization Products

Decision Date2012-09-14

Product CodeFRC

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

STERRAD (R) CYCLESURE (R) 24 BIOLOGICAL INDICATOR is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Sterilization Products. It received FDA 510(k) clearance on 2012-09-14 under 510(k) number K111375. The device is classified under product code FRC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STERRAD (R) CYCLESURE (R) 24 BIOLOGICAL INDICATOR?

STERRAD (R) CYCLESURE (R) 24 BIOLOGICAL INDICATOR is a medical device that received FDA 510(k) clearance on 2012-09-14. The listed applicant is Advanced Sterilization Products. The 510(k) number is K111375.

When did STERRAD (R) CYCLESURE (R) 24 BIOLOGICAL INDICATOR receive FDA 510(k) clearance?

STERRAD (R) CYCLESURE (R) 24 BIOLOGICAL INDICATOR received FDA 510(k) clearance on 2012-09-14, under 510(k) number K111375.

Who is the listed applicant for STERRAD (R) CYCLESURE (R) 24 BIOLOGICAL INDICATOR?

The FDA 510(k) record lists Advanced Sterilization Products as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STERRAD (R) CYCLESURE (R) 24 BIOLOGICAL INDICATOR?

The FDA product code for STERRAD (R) CYCLESURE (R) 24 BIOLOGICAL INDICATOR is FRC.

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Other records listing Advanced Sterilization Products as applicant

K234082STERRAD® 100NX Sterilizer with ALLClear™ Technology and ULTRA GI™ Cycle (10104); APTIMAX™ Instrument Tray for ULTRA GI™ Cycle (011077)K163598Tyvek Self-Seal Pouches with STERRAD Chemical Indicator, Tyvek Rolls with STERRAD Chemical Indicator, Tyvek Heat-Seal Pouches with STERRAD Chemical Indicator K162007STERRAD NX Sterilizer K160818STERRAD® NX Sterilizer with ALLClear™ Technology K160903STERRAD 100NX Sterilizer with ALLClearTM Technology K151725STERRAD NX Sterilizer, STERRAD 100NX Sterilizer

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.