Cleared Special

Transducer Probe Cover

K241615 · Hony Medical Co., Ltd. · Radiology
Jul 2024
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K241615 is an FDA 510(k) clearance for the Transducer Probe Cover, a Transducer, Ultrasonic, Diagnostic (Class II — Special Controls, product code ITX), submitted by Hony Medical Co., Ltd. (Taishan, CN). The FDA issued a Cleared decision on July 3, 2024, 28 days after receiving the submission on June 5, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1570.

Submission Details

510(k) Number K241615 FDA.gov
FDA Decision Cleared SESE
Date Received June 05, 2024
Decision Date July 03, 2024
Days to Decision 28 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code ITX — Transducer, Ultrasonic, Diagnostic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1570

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