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FDA 510(k)

PRO-LITE Sterilization Tray

K-Number: K183301 · 2019-01-03

ApplicantSTERIS Corporation
Decision Date2019-01-03
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PRO-LITE Sterilization Tray is the device name listed in this FDA 510(k) record. The listed applicant is STERIS Corporation. It received FDA 510(k) clearance on 2019-01-03 under 510(k) number K183301. 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 Tray?

PRO-LITE Sterilization Tray is a medical device that received FDA 510(k) clearance on 2019-01-03. The listed applicant is STERIS Corporation. The 510(k) number is K183301.

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

PRO-LITE Sterilization Tray received FDA 510(k) clearance on 2019-01-03, under 510(k) number K183301.

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

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 Tray?

The FDA product code for PRO-LITE Sterilization Tray 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.

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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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