Cleared Traditional

Transducer Probe Cover

K221278 · Hony Medical Co., Ltd. · Radiology
Jan 2023
Decision
253d
Days
Class 2
Risk

About This 510(k) Submission

K221278 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 January 11, 2023, 253 days after receiving the submission on May 3, 2022. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1570.

Submission Details

510(k) Number K221278 FDA.gov
FDA Decision Cleared SESE
Date Received May 03, 2022
Decision Date January 11, 2023
Days to Decision 253 days
Submission Type Traditional
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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