FDA 510(k)

Aygün Sterilization Container Systems

Numéro K : K233222 · 2023-12-12

DemandeurAygun Surgical Instruments Co., Inc.

Date de décision2023-12-12

Code produitKCT

Comité consultatifHO

DécisionSubstantially Equivalent

Résumé du dispositif

Aygün Sterilization Container Systems is the device name listed in this FDA 510(k) record. The listed applicant is Aygun Surgical Instruments Co., Inc.. It received FDA 510(k) clearance on 2023-12-12 under 510(k) number K233222. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Aygün Sterilization Container Systems?

Aygün Sterilization Container Systems is a medical device that received FDA 510(k) clearance on 2023-12-12. The listed applicant is Aygun Surgical Instruments Co., Inc.. The 510(k) number is K233222.

When did Aygün Sterilization Container Systems receive FDA 510(k) clearance?

Aygün Sterilization Container Systems received FDA 510(k) clearance on 2023-12-12, under 510(k) number K233222.

Who is the listed applicant for Aygün Sterilization Container Systems?

The FDA 510(k) record lists Aygun Surgical Instruments Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Aygün Sterilization Container Systems?

The FDA product code for Aygün Sterilization Container Systems is KCT.

Essais cliniques associés

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Dispositifs connexes (Code : KCT)

K253988LiteSet TraysNobel Biocare AB K261935Surgical and Prosthetic TraysDentsply Sirona, Inc.K253187SteriBest® Sterilization Tray SystemMastel Surgical K252854SteriTite Container System with MediTray ProductsCase Medical, Inc.K260726Straumann® ProClean™ Cassette (041.800 ; 041.801)Institut Straumann AG K253791PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System LidDePuy Mitek, Inc.

Source officielle

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