FDA 510(k)

Sonopet iQ Sterilization Tray

K-Number: K190667 · 2019-06-13

Decision Date2019-06-13

Product CodeKCT

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Sonopet iQ Sterilization Tray is a medical device manufactured by Paragon Medical. It received FDA 510(k) clearance on 2019-06-13 under approval number K190667. 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 Sonopet iQ Sterilization Tray?

Sonopet iQ Sterilization Tray is a medical device that received FDA 510(k) clearance on 2019-06-13. It is manufactured by Paragon Medical. The 510(k) number is K190667.

When was Sonopet iQ Sterilization Tray approved by the FDA?

Sonopet iQ Sterilization Tray received FDA 510(k) clearance on 2019-06-13, under approval number K190667.

What company makes Sonopet iQ Sterilization Tray?

Sonopet iQ Sterilization Tray is manufactured by Paragon Medical.

What is the FDA product code for Sonopet iQ Sterilization Tray?

The FDA product code for Sonopet iQ Sterilization Tray is KCT.

Other Devices by Paragon Medical

K173615Stryker Universal Select Sterilization Tray System 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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.