Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

VERIFY Assert Self-Contained Biological Indicator

K-Number: K181442 · 2018-06-13

ApplicantSTERIS Corporation
Decision Date2018-06-13
Product CodeOWP
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

VERIFY Assert Self-Contained Biological Indicator is a medical device manufactured by STERIS Corporation. It received FDA 510(k) clearance on 2018-06-13 under approval number K181442. 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 2018-06-13. It is manufactured by STERIS Corporation. The 510(k) number is K181442.

When was VERIFY Assert Self-Contained Biological Indicator approved by the FDA?

VERIFY Assert Self-Contained Biological Indicator received FDA 510(k) clearance on 2018-06-13, under approval number K181442.

What company makes VERIFY Assert Self-Contained Biological Indicator?

VERIFY Assert Self-Contained Biological Indicator is manufactured by STERIS Corporation.

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.

Related Clinical Trials

NCT06355713 Improvement of Symptoms After Removal of the Essure® Contraceptive Implant RECRUITING NCT07505784 Transcranial Alternating Current Stimulation in Frontotemporal Dementia RECRUITING

Other Devices by STERIS Corporation

K160912Sterilization Tray K161683SYSTEM 1E Liquid Chemical Sterilant Processing System K160908Vis-U-All Low Temperature Sterilization Pouch/Tubing K160433V-PRO® 1 Plus and V-PRO® maX Low Temperature K160485VERIFY VH2O2 Indicator Tape K152630VERIFY STEAM Integrating Indicator

View all 119 devices →

Related Devices (Code: OWP)

K162945VERIFY ASSERT STEAM Process Challenge DeviceSTERIS Corporation K162701VERIFY Assert Self-Contained Biological IndicatorSTERIS 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.

↑