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FDA 510(k)

STERRAD VELOCITY Biological Indictator and Reader

K-Number: K170039 · 2017-06-20

ApplicantAdvanced Sterilization Products (Asp)
Decision Date2017-06-20
Product CodeFRC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

STERRAD VELOCITY Biological Indictator and Reader is a medical device manufactured by Advanced Sterilization Products (Asp). It received FDA 510(k) clearance on 2017-06-20 under approval number K170039. 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 VELOCITY Biological Indictator and Reader?

STERRAD VELOCITY Biological Indictator and Reader is a medical device that received FDA 510(k) clearance on 2017-06-20. It is manufactured by Advanced Sterilization Products (Asp). The 510(k) number is K170039.

When was STERRAD VELOCITY Biological Indictator and Reader approved by the FDA?

STERRAD VELOCITY Biological Indictator and Reader received FDA 510(k) clearance on 2017-06-20, under approval number K170039.

What company makes STERRAD VELOCITY Biological Indictator and Reader?

STERRAD VELOCITY Biological Indictator and Reader is manufactured by Advanced Sterilization Products (Asp).

What is the FDA product code for STERRAD VELOCITY Biological Indictator and Reader?

The FDA product code for STERRAD VELOCITY Biological Indictator and Reader is FRC.

Other Devices by Advanced Sterilization Products (Asp)

K152189EVOTECH ECR K182404STERRAD VELOCITY Biological Indicator K181472AEROFLEX(TM) Automatic Endoscope Reprocessor with AUTOSURE(TM) MRC Monitor K192025STERRAD VELOCITY Biological Indicator/Process Challenge Device and Reader

Related Devices (Code: FRC)

K1605463M Attest Rapid Readout Biological Indicator3M Company K151482BCR-30-min BI™ and RBIP-ST30™ Readout AccessoryBcr Diagnostics, Inc. K172474Celerity 20 HP Biological IndicatorSTERIS Corporation K172432SporView Rapid Read Biological IndicatorCrosstex/Spsmedical, A Division of Cantel Medical K163646Terragene Bionova(R) SCBI (BT220, BT221, BT222, BT223), Terragene Bionova (R) PCD (PCD220-C, PCD220-2, PCD222-C, PCD222-2), and Terragene Bionova(R) IC10/20FR Reader IncubatorTerragene S.A. K170427Anprolene SteriTestAndersen Sterilizers, Inc.

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.

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