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FDA 510(k)

PRO-LITE Sterilization Trays

K-Number: K172755 · 2018-02-09

ApplicantSTERIS Corporation
Decision Date2018-02-09
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PRO-LITE Sterilization Trays is the device name listed in this FDA 510(k) record. The listed applicant is STERIS Corporation. It received FDA 510(k) clearance on 2018-02-09 under 510(k) number K172755. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRO-LITE Sterilization Trays?

PRO-LITE Sterilization Trays is a medical device that received FDA 510(k) clearance on 2018-02-09. The listed applicant is STERIS Corporation. The 510(k) number is K172755.

When did PRO-LITE Sterilization Trays receive FDA 510(k) clearance?

PRO-LITE Sterilization Trays received FDA 510(k) clearance on 2018-02-09, under 510(k) number K172755.

Who is the listed applicant for PRO-LITE Sterilization Trays?

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 PRO-LITE Sterilization Trays?

The FDA product code for PRO-LITE Sterilization Trays is KCT.

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 SterilizerK260766Celerity 5 HP Biological Indicator (LCB052)K251666SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700; SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900K252680Celerity™ 20 HP Biological IndicatorK251452Celerity 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

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Related Devices (Code: KCT)

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.

K253187SteriBest® Sterilization Tray SystemMastel SurgicalK260726Straumann® ProClean™ Cassette (041.800 ; 041.801)Institut Straumann AGK252854SteriTite Container System with MediTray ProductsCase Medical, Inc.K253791PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System LidDePuy Mitek, Inc.K251614Stainless Steel Surgical KitsDentsply Sirona, Inc.K251756Sterilization TraysParagon Implant Mfg., LLC

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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