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FDA 510(k)

Stryker ChestShield Sterilization Tray System

K-Number: K183701 · 2019-05-07

ApplicantParagon Medical
Decision Date2019-05-07
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Stryker ChestShield Sterilization Tray System is a medical device manufactured by Paragon Medical. It received FDA 510(k) clearance on 2019-05-07 under approval number K183701. 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 ChestShield Sterilization Tray System?

Stryker ChestShield Sterilization Tray System is a medical device that received FDA 510(k) clearance on 2019-05-07. It is manufactured by Paragon Medical. The 510(k) number is K183701.

When was Stryker ChestShield Sterilization Tray System approved by the FDA?

Stryker ChestShield Sterilization Tray System received FDA 510(k) clearance on 2019-05-07, under approval number K183701.

What company makes Stryker ChestShield Sterilization Tray System?

Stryker ChestShield Sterilization Tray System is manufactured by Paragon Medical.

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

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

Related Clinical Trials

NCT04610294 Operating Room Air Filtration/Sterilization ACTIVE_NOT_RECRUITING NCT06941558 The UK ADAPTIS Study ACTIVE_NOT_RECRUITING NCT07245719 Stryker Universal Midface and Upper-Face Fixation System: A Retrospective Post Market Follow Up COMPLETED NCT04195568 Evaluation of Safety and Effectiveness of Stryker Surpass Evolve™ Flow Diverter System ACTIVE_NOT_RECRUITING

Other Devices by Paragon Medical

K173615Stryker Universal Select Sterilization Tray System K190667Sonopet iQ Sterilization Tray

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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