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FDA 510(k)

Aygün Sterilization Container Systems

K-Number: K233222 · 2023-12-12

ApplicantAygun Surgical Instruments Co., Inc.
Decision Date2023-12-12
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

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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