FDA 510(k)

PICOCLAMP

K-Number: K230281 · 2023-10-23

Decision Date2023-10-23

Product CodeDXC

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

PICOCLAMP is a medical device manufactured by Kono Seisakusho Co., Ltd.. It received FDA 510(k) clearance on 2023-10-23 under approval number K230281. The device is classified under product code DXC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PICOCLAMP?

PICOCLAMP is a medical device that received FDA 510(k) clearance on 2023-10-23. It is manufactured by Kono Seisakusho Co., Ltd.. The 510(k) number is K230281.

When was PICOCLAMP approved by the FDA?

PICOCLAMP received FDA 510(k) clearance on 2023-10-23, under approval number K230281.

What company makes PICOCLAMP?

PICOCLAMP is manufactured by Kono Seisakusho Co., Ltd..

What is the FDA product code for PICOCLAMP?

The FDA product code for PICOCLAMP is DXC.

Other Devices by Kono Seisakusho Co., Ltd.

K192420Crownjun Nylon Suture

Related Devices (Code: DXC)

K162027TRAcelet Compression DeviceMedtronic Vascular K161315Vein Clamps, Artery ClampsAros Surgical Instruments Corporation K153259VasoStat Hemostasis DeviceForge Medical, Inc. K170958ChitoPulse 9in / 23 cm, ChitoPulse 12in / 30.5 cm, ChitoPulse 15in / 38 cmTricol Biomedical, Inc. K163693IntraClude Intra-Aortic Occlusion DeviceEdwards Lifesciences, LLC K162988PreludeSYNC Radial Compression DeviceMerit Medical Systems, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.