FDA 510(k)

VERIFY Assert Self-Contained Biological Indicator

K-Number: K162701 · 2017-03-24

Decision Date2017-03-24

Product CodeOWP

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

VERIFY Assert Self-Contained Biological Indicator is the device name listed in this FDA 510(k) record. The listed applicant is STERIS Corporation. It received FDA 510(k) clearance on 2017-03-24 under 510(k) number K162701. The device is classified under product code OWP. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VERIFY Assert Self-Contained Biological Indicator?

VERIFY Assert Self-Contained Biological Indicator is a medical device that received FDA 510(k) clearance on 2017-03-24. The listed applicant is STERIS Corporation. The 510(k) number is K162701.

When did VERIFY Assert Self-Contained Biological Indicator receive FDA 510(k) clearance?

VERIFY Assert Self-Contained Biological Indicator received FDA 510(k) clearance on 2017-03-24, under 510(k) number K162701.

Who is the listed applicant for VERIFY Assert Self-Contained Biological Indicator?

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

What is the FDA product code for VERIFY Assert Self-Contained Biological Indicator?

The FDA product code for VERIFY Assert Self-Contained Biological Indicator is OWP.

Other records listing STERIS Corporation 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.

K261055AMSCO 700 Steam Sterilizer K260766Celerity 5 HP Biological Indicator (LCB052)K251666SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700; SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 K252680Celerity™ 20 HP Biological Indicator K251452Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045)K251048Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118

View all 139 devices →

Related Devices (Code: OWP)

K181442VERIFY Assert Self-Contained Biological IndicatorSTERIS Corporation K162945VERIFY ASSERT STEAM Process Challenge DeviceSTERIS Corporation K163587VERIFY Incubator for Assert Self Contained Biological IndicatorsSTERIS Corporation

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.