Cleared Traditional

Sterile and Non-Sterile Ultrasound Gels

K232957 · Jianerkang Medical Co., Ltd. · Radiology

Dec 2023

Decision

85d

Days

Class 2

Risk

About This 510(k) Submission

K232957 is an FDA 510(k) clearance for the Sterile and Non-Sterile Ultrasound Gels, a Media, Coupling, Ultrasound (Class II — Special Controls, product code MUI), submitted by Jianerkang Medical Co., Ltd. (Changzhou, CN). The FDA issued a Cleared decision on December 15, 2023, 85 days after receiving the submission on September 21, 2023. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1570.

Submission Details

510(k) Number	K232957 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 21, 2023
Decision Date	December 15, 2023
Days to Decision	85 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF