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FDA 510(k)

Sonopet iQ Sterilization Tray

K-Number: K190667 · 2019-06-13

ApplicantParagon Medical
Decision Date2019-06-13
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Sonopet iQ Sterilization Tray is the device name listed in this FDA 510(k) record. The listed applicant is Paragon Medical. It received FDA 510(k) clearance on 2019-06-13 under 510(k) 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. The listed applicant is Paragon Medical. The 510(k) number is K190667.

When did Sonopet iQ Sterilization Tray receive FDA 510(k) clearance?

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

Who is the listed applicant for Sonopet iQ Sterilization Tray?

The FDA 510(k) record lists Paragon Medical as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Paragon Medical 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.

K183701Stryker ChestShield Sterilization Tray SystemK173615Stryker Universal Select Sterilization Tray System

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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