Cleared Traditional

Flush Syringe (Prefilled 0.9% normal saline solution)

K231724 · Spm Medicare Pvt. , Ltd. · General Hospital

Nov 2023

Decision

149d

Days

Class 2

Risk

About This 510(k) Submission

K231724 is an FDA 510(k) clearance for the Flush Syringe (Prefilled 0.9% normal saline solution), a Saline, Vascular Access Flush (Class II — Special Controls, product code NGT), submitted by Spm Medicare Pvt. , Ltd. (Gautam Budh Nagar, IN). The FDA issued a Cleared decision on November 9, 2023, 149 days after receiving the submission on June 13, 2023. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5200.

Submission Details

510(k) Number	K231724 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 13, 2023
Decision Date	November 09, 2023
Days to Decision	149 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF

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.