Cleared Traditional

Ultrasound Transmission Gels

K221999 · Hony Medical Co., Ltd. · Radiology
Aug 2022
Decision
54d
Days
Class 2
Risk

About This 510(k) Submission

K221999 is an FDA 510(k) clearance for the Ultrasound Transmission Gels, a Media, Coupling, Ultrasound (Class II — Special Controls, product code MUI), submitted by Hony Medical Co., Ltd. (Taishan, CN). The FDA issued a Cleared decision on August 30, 2022, 54 days after receiving the submission on July 7, 2022. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1570.

Submission Details

510(k) Number K221999 FDA.gov
FDA Decision Cleared SESE
Date Received July 07, 2022
Decision Date August 30, 2022
Days to Decision 54 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code MUI — Media, Coupling, Ultrasound
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1570

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