Cleared Traditional

K230281 - PICOCLAMP (FDA 510(k) Clearance)

K230281 · Kono Seisakusho Co., Ltd. · Cardiovascular device

Oct 2023

Decision

264d

Days

Class 2

Risk

K230281 is an FDA 510(k) clearance for the PICOCLAMP. This device is classified as 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 FDA review panel. Regulated under 21 CFR 870.4450.

Submission Details

510(k) Number	K230281 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (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