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FDA 510(k)

STERRAD VELOCITY Biological Indicator

K-Number: K182404 · 2018-12-27

ApplicantAdvanced Sterilization Products (Asp)
Decision Date2018-12-27
Product CodeFRC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

STERRAD VELOCITY Biological Indicator is a medical device manufactured by Advanced Sterilization Products (Asp). It received FDA 510(k) clearance on 2018-12-27 under approval number K182404. 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 Indicator?

STERRAD VELOCITY Biological Indicator is a medical device that received FDA 510(k) clearance on 2018-12-27. It is manufactured by Advanced Sterilization Products (Asp). The 510(k) number is K182404.

When was STERRAD VELOCITY Biological Indicator approved by the FDA?

STERRAD VELOCITY Biological Indicator received FDA 510(k) clearance on 2018-12-27, under approval number K182404.

What company makes STERRAD VELOCITY Biological Indicator?

STERRAD VELOCITY Biological Indicator is manufactured by Advanced Sterilization Products (Asp).

What is the FDA product code for STERRAD VELOCITY Biological Indicator?

The FDA product code for STERRAD VELOCITY Biological Indicator is FRC.

Related Clinical Trials

NCT07289698 Handgrip Strength Increases the Pressure in the Portal and Left Gastric Veins in Cirrhotic Patients COMPLETED

Other Devices by Advanced Sterilization Products (Asp)

K152189EVOTECH ECR K170039STERRAD VELOCITY Biological Indictator and Reader 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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