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FDA 510(k)

Stryker Universal Select Sterilization Tray System

K-Number: K173615 · 2018-04-18

ApplicantParagon Medical
Decision Date2018-04-18
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Stryker Universal Select Sterilization Tray System is a medical device manufactured by Paragon Medical. It received FDA 510(k) clearance on 2018-04-18 under approval number K173615. 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 Stryker Universal Select Sterilization Tray System?

Stryker Universal Select Sterilization Tray System is a medical device that received FDA 510(k) clearance on 2018-04-18. It is manufactured by Paragon Medical. The 510(k) number is K173615.

When was Stryker Universal Select Sterilization Tray System approved by the FDA?

Stryker Universal Select Sterilization Tray System received FDA 510(k) clearance on 2018-04-18, under approval number K173615.

What company makes Stryker Universal Select Sterilization Tray System?

Stryker Universal Select Sterilization Tray System is manufactured by Paragon Medical.

What is the FDA product code for Stryker Universal Select Sterilization Tray System?

The FDA product code for Stryker Universal Select Sterilization Tray System is KCT.

Related Clinical Trials

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Other Devices by Paragon Medical

K190667Sonopet iQ Sterilization Tray K183701Stryker ChestShield Sterilization Tray System

Related Devices (Code: KCT)

K160574K3PRO SURGICAL TRAYArgon Med. Productions Vertriebs Gesellschaft Mbh CO KG K162600Jewel Precision Reusable Rigid Sterilization Container SystemJewel Precision Sheet Metal & Machine, Inc. K160912Sterilization TraySTERIS Corporation K161347Signia sterilization trayCovidien K152745ReNew Sterilization Trays(Catalog #3708 and #3709)Microline Surgical, Inc. K152111Symmetry Surgical Quad-Lock Container SystemSymmetry Surgical, Inc.

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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