Cleared Traditional

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

K253791 · DePuy Mitek, Inc. · General Hospital

Feb 2026

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K253791 is an FDA 510(k) clearance for the PUREVUE? Quick Connect Cannula System Tray; PUREVUE? Quick Connect Cannula System Lid, a Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (Class II — Special Controls, product code KCT), submitted by DePuy Mitek, Inc. (Raynham, US). The FDA issued a Cleared decision on February 26, 2026, 90 days after receiving the submission on November 28, 2025. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6850.

Submission Details

510(k) Number	K253791 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 28, 2025
Decision Date	February 26, 2026
Days to Decision	90 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF

Device Classification

Product Code	KCT — Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 880.6850