Cleared Traditional

Surgical Sutures with or without Needle

K221767 · Huaian Seamen Medical Technology Co., Ltd. · General & Plastic Surgery

Jul 2023

Decision

409d

Days

Class 2

Risk

About This 510(k) Submission

K221767 is an FDA 510(k) clearance for the Surgical Sutures with or without Needle, a Suture, Nonabsorbable, Silk (Class II — Special Controls, product code GAP), submitted by Huaian Seamen Medical Technology Co., Ltd. (Huaian, CN). The FDA issued a Cleared decision on July 31, 2023, 409 days after receiving the submission on June 17, 2022. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.5030.

Submission Details

510(k) Number	K221767 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 17, 2022
Decision Date	July 31, 2023
Days to Decision	409 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF