Cleared Traditional

SOLID CLIP? Single Use Clip Applier

K221495 · Medscope Biotech Co., Ltd. · General & Plastic Surgery

Jul 2024

Decision

787d

Days

Class 2

Risk

About This 510(k) Submission

K221495 is an FDA 510(k) clearance for the SOLID CLIP? Single Use Clip Applier, a Clip, Implantable (Class II — Special Controls, product code FZP), submitted by Medscope Biotech Co., Ltd. (Miaoli County, TW). The FDA issued a Cleared decision on July 18, 2024, 787 days after receiving the submission on May 23, 2022. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4300.

Submission Details

510(k) Number	K221495 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 23, 2022
Decision Date	July 18, 2024
Days to Decision	787 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF