Cleared Traditional

TK Pre-Filled Normal Saline Flush Syringe

K230756 · Anhui Tiankang Medical Technology Co., Ltd. · General Hospital

Aug 2023

Decision

145d

Days

Class 2

Risk

About This 510(k) Submission

K230756 is an FDA 510(k) clearance for the TK Pre-Filled Normal Saline Flush Syringe, a Saline, Vascular Access Flush (Class II — Special Controls, product code NGT), submitted by Anhui Tiankang Medical Technology Co., Ltd. (Tianchang, CN). The FDA issued a Cleared decision on August 12, 2023, 145 days after receiving the submission on March 20, 2023. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5200.

Submission Details

510(k) Number	K230756 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 20, 2023
Decision Date	August 12, 2023
Days to Decision	145 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Statement

Device Classification

Product Code	NGT — Saline, Vascular Access Flush
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 880.5200
Definition	Enhance The Performance Of Intravascular Catheters, To Maintain Patency Of The Vascular Catheter When It Is Not In Use.