Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SteriZign Signatur Device Protection System

K-Number: K171520 · 2018-02-07

ApplicantSterizign Precision Technologies, LLC
Decision Date2018-02-07
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SteriZign Signatur Device Protection System is the device name listed in this FDA 510(k) record. The listed applicant is Sterizign Precision Technologies, LLC. It received FDA 510(k) clearance on 2018-02-07 under 510(k) number K171520. 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 SteriZign Signatur Device Protection System?

SteriZign Signatur Device Protection System is a medical device that received FDA 510(k) clearance on 2018-02-07. The listed applicant is Sterizign Precision Technologies, LLC. The 510(k) number is K171520.

When did SteriZign Signatur Device Protection System receive FDA 510(k) clearance?

SteriZign Signatur Device Protection System received FDA 510(k) clearance on 2018-02-07, under 510(k) number K171520.

Who is the listed applicant for SteriZign Signatur Device Protection System?

The FDA 510(k) record lists Sterizign Precision Technologies, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SteriZign Signatur Device Protection System?

The FDA product code for SteriZign Signatur Device Protection System is KCT.

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.

↑