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FDA 510(k)

K3PRO SURGICAL TRAY

K-Number: K160574 · 2016-12-20

ApplicantArgon Med. Productions Vertriebs Gesellschaft Mbh CO KG
Decision Date2016-12-20
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

K3PRO SURGICAL TRAY is the device name listed in this FDA 510(k) record. The listed applicant is Argon Med. Productions Vertriebs Gesellschaft Mbh CO KG. It received FDA 510(k) clearance on 2016-12-20 under 510(k) number K160574. 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 K3PRO SURGICAL TRAY?

K3PRO SURGICAL TRAY is a medical device that received FDA 510(k) clearance on 2016-12-20. The listed applicant is Argon Med. Productions Vertriebs Gesellschaft Mbh CO KG. The 510(k) number is K160574.

When did K3PRO SURGICAL TRAY receive FDA 510(k) clearance?

K3PRO SURGICAL TRAY received FDA 510(k) clearance on 2016-12-20, under 510(k) number K160574.

Who is the listed applicant for K3PRO SURGICAL TRAY?

The FDA 510(k) record lists Argon Med. Productions Vertriebs Gesellschaft Mbh CO KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for K3PRO SURGICAL TRAY?

The FDA product code for K3PRO SURGICAL TRAY is KCT.

Other records listing Argon Med. Productions Vertriebs Gesellschaft Mbh CO KG 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.

K190192K3Pro Konus New Abutments and ImplantsK160581K3PRO Konus Additional Abutments and Implants

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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