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 STEAM Process Challenge Device

K-Number: K162945 · 2017-04-28

ApplicantSTERIS Corporation
Decision Date2017-04-28
Product CodeOWP
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

VERIFY ASSERT STEAM Process Challenge Device is a medical device manufactured by STERIS Corporation. It received FDA 510(k) clearance on 2017-04-28 under approval number K162945. 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 STEAM Process Challenge Device?

VERIFY ASSERT STEAM Process Challenge Device is a medical device that received FDA 510(k) clearance on 2017-04-28. It is manufactured by STERIS Corporation. The 510(k) number is K162945.

When was VERIFY ASSERT STEAM Process Challenge Device approved by the FDA?

VERIFY ASSERT STEAM Process Challenge Device received FDA 510(k) clearance on 2017-04-28, under approval number K162945.

What company makes VERIFY ASSERT STEAM Process Challenge Device?

VERIFY ASSERT STEAM Process Challenge Device is manufactured by STERIS Corporation.

What is the FDA product code for VERIFY ASSERT STEAM Process Challenge Device?

The FDA product code for VERIFY ASSERT STEAM Process Challenge Device is OWP.

Related Clinical Trials

NCT07613658 3D-Printed Versus Band-and-Loop Versus Denovo Space Maintainers in Primary Dentition. NOT_YET_RECRUITING NCT07595510 NaviFast 6D for Limb Length Measurement During Total Hip Arthroplasty COMPLETED NCT05906004 Post-Market Clinical Follow-up (PMCF) Study of the Pitch-Patch for the Augmentation or Reinforcement of the Rotator Cuff RECRUITING NCT05264389 Post-market Clinical Follow-up (PMCF) Study of the Poly-Tape Devices for Medial Patellofemoral Ligament (MPFL) Reconstruction ACTIVE_NOT_RECRUITING NCT06172699 Assert-IQ Implantable Cardiac Monitor (ICM) Post Market Study COMPLETED NCT06832163 Close Loop Smart Weaning for INO With PPHN RECRUITING

Related PubMed Literature

PMID: 42105288 Evaluating regulatory oversight through major Expert review of medical devices (2026) PMID: 41970523 Large language models in healthcare quality management: a European perspective on process automation and compliance. Frontiers in digital health (2026) PMID: 41813332 Developing Clinical Decision (Support) Systems Combining the Scientific and Regulatory Perspective: European Insights on Challenges, Requirements, and Practical Guidance. JMIR medical informatics (2026) PMID: 41572440 Regulating Medical Devices: The Values and Politics of the US FDA Review Process. The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics (2026)

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)

K162701VERIFY Assert Self-Contained Biological IndicatorSTERIS Corporation K163587VERIFY Incubator for Assert Self Contained Biological IndicatorsSTERIS Corporation K181442VERIFY Assert Self-Contained Biological IndicatorSTERIS 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.

↑