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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 the device name listed in this FDA 510(k) record. The listed applicant is Advanced Sterilization Products (Asp). It received FDA 510(k) clearance on 2018-12-27 under 510(k) 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. The listed applicant is Advanced Sterilization Products (Asp). The 510(k) number is K182404.

When did STERRAD VELOCITY Biological Indicator receive FDA 510(k) clearance?

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

Who is the listed applicant for STERRAD VELOCITY Biological Indicator?

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

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

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

Other records listing Advanced Sterilization Products (Asp) as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K192025STERRAD VELOCITY Biological Indicator/Process Challenge Device and ReaderK181472AEROFLEX(TM) Automatic Endoscope Reprocessor with AUTOSURE(TM) MRC MonitorK170039STERRAD VELOCITY Biological Indictator and ReaderK152189EVOTECH ECR

Related Devices (Code: FRC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260766Celerity 5 HP Biological Indicator (LCB052)STERIS CorporationK252680Celerity™ 20 HP Biological IndicatorSTERIS CorporationK251122Terragene® Bionova® BT20 Biological IndicatorTerrageneK251452Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045)SterisK250061Celerity IncubatorSTERIS CorporationK250044Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045)STERIS Corporation

Official Source

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

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