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FDA 510(k)

PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System Lid

K-Number: K253791 · 2026-02-26

ApplicantDePuy Mitek, Inc.
Decision Date2026-02-26
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System Lid is the device name listed in this FDA 510(k) record. The listed applicant is DePuy Mitek, Inc.. It received FDA 510(k) clearance on 2026-02-26 under 510(k) number K253791. 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 PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System Lid?

PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System Lid is a medical device that received FDA 510(k) clearance on 2026-02-26. The listed applicant is DePuy Mitek, Inc.. The 510(k) number is K253791.

When did PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System Lid receive FDA 510(k) clearance?

PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System Lid received FDA 510(k) clearance on 2026-02-26, under 510(k) number K253791.

Who is the listed applicant for PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System Lid?

The FDA 510(k) record lists DePuy Mitek, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System Lid?

The FDA product code for PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System Lid is KCT.

Other records listing DePuy Mitek, Inc. 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.

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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.K251614Stainless Steel Surgical KitsDentsply Sirona, Inc.K251756Sterilization TraysParagon Implant Mfg., LLCK251300Plastic Surgical KitsDentsply Sirona, Inc.

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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