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FDA 510(k)

Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide

K-Number: K203223 · 2021-01-28

ApplicantSteris
Decision Date2021-01-28
Product CodeNZA
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide is a medical device manufactured by Steris. It received FDA 510(k) clearance on 2021-01-28 under approval number K203223. The device is classified under product code NZA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide?

Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide is a medical device that received FDA 510(k) clearance on 2021-01-28. It is manufactured by Steris. The 510(k) number is K203223.

When was Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide approved by the FDA?

Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide received FDA 510(k) clearance on 2021-01-28, under approval number K203223.

What company makes Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide?

Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide is manufactured by Steris.

What is the FDA product code for Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide?

The FDA product code for Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide is NZA.

Related Clinical Trials

NCT07531901 Evaluating the Feasibility and Reliability of Using Handheld Nebulizers to Conduct Cough Sensitivity Testing With Citric Acid NOT_YET_RECRUITING NCT06868979 Optical Imaging in X-linked Disorders. RECRUITING NCT03819608 Neuromodulation and Neurorehabilitation for mTBI RECRUITING NCT07089615 Prospective, Open-label, Non-significant Risk, Multicenter Study Comparing the Polyp Detection of the Study Device to That of the Colonoscopy Reference RECRUITING NCT07063381 Low-frequency Electrical Stimulation for Cognitive Enhancement in Atrial Fibrillation ENROLLING_BY_INVITATION NCT04462250 Mobile Health (mHealth) App for Safe Opioid Use WITHDRAWN

Related PubMed Literature

PMID: 42056377 Signal detection of adverse events in medical devices using natural language processing: a case study in pelvic mesh. Scientific reports (2026)

Other Devices by Steris

K222849AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System, RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP and 7053HP Single Chamber Washer Disinfector K222093V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System K222440Vis-U-All Low Temperature Sterilization Pouches/Tubing, PRO-LITE Sterilization Trays K222543AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2 Low Temperature Sterilization System, RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP and 7053HP Single Chamber Washer Disinfector K220473CELERITY 20 HP Challenge Pack K233654VERIFY® Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems

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Related Devices (Code: NZA)

K200989Reliance Endoscope Processing SystemSTERIS Corporation K220361Reliance EPS Endoscope Processing System and Reliance DG Dry GermicideSTERIS Corporation K232918enspire 300 Series Automated Endoscope ReprocessorSTERIS Corporation K230560enspire 300 Series Automated Endoscope Reprocessor SystemSTERIS 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.

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