Cleared Traditional

Non-Sterile Ultrasound Transmission Gels

K241789 · Hony Medical Co., Ltd. · Radiology

Jul 2024

Decision

33d

Days

Class 2

Risk

About This 510(k) Submission

K241789 is an FDA 510(k) clearance for the Non-Sterile 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 July 24, 2024, 33 days after receiving the submission on June 21, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1570.

Submission Details

510(k) Number	K241789 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 21, 2024
Decision Date	July 24, 2024
Days to Decision	33 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF