Cleared Traditional

PICOCLAMP

K230281 · Kono Seisakusho Co., Ltd. · Cardiovascular

Oct 2023

Decision

264d

Days

Class 2

Risk

About This 510(k) Submission

K230281 is an FDA 510(k) clearance for the PICOCLAMP, a Clamp, Vascular (Class II — Special Controls, product code DXC), submitted by Kono Seisakusho Co., Ltd. (Ichikawa City, JP). The FDA issued a Cleared decision on October 23, 2023, 264 days after receiving the submission on February 1, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4450.

Submission Details

510(k) Number	K230281 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 01, 2023
Decision Date	October 23, 2023
Days to Decision	264 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF