PUREVUE Quick Connect Cannula System Tray; PUREVUE Quick Connect Cannula System Lid— 510(k) K253791

Name: FDA 510(k) clearance K253791
Creator: U.S. Food and Drug Administration
Published: 2026-02-26

Substantially Equivalent

DePuy Mitek, Inc.

FDA 510(k) clearance K253791 for PUREVUE Quick Connect Cannula System Tray; PUREVUE Quick Connect Cannula System Lid, Substantially Equivalent on 2026-02-26. Applicant: DePuy Mitek, Inc.. Device class: 2.

Summary

DePuy Mitek filed two items, the PUREVUE Quick Connect Cannula System Tray and the PUREVUE Quick Connect Cannula System Lid, under product code KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories). The record doesn't describe either one beyond its name and that code name.

Class II, 21 CFR 880.6850. General Hospital is both the classification panel and the review panel, and it came in as a Traditional 510(k).

DePuy Mitek filed from Raynham, Massachusetts. The decision came 90 calendar days after FDA received it (November 28, 2025 to February 26, 2026), and it was substantially equivalent.

Clearance details

Applicant: DePuy Mitek, Inc.
Product code: Product code KCT
Device class: Class 2
Regulation: 21 CFR 880.6850
Advisory panel: General Hospital
Date received: 2025-11-28
Decision date: 2026-02-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Raynham, MA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.