Cleared Traditional

Three Way Stop Cock

K223499 · M/S Romsons International · General Hospital

Jul 2023

Decision

242d

Days

Class 2

Risk

About This 510(k) Submission

K223499 is an FDA 510(k) clearance for the Three Way Stop Cock, a Stopcock, I.v. Set (Class II — Special Controls, product code FMG), submitted by M/S Romsons International (Noida, IN). The FDA issued a Cleared decision on July 21, 2023, 242 days after receiving the submission on November 21, 2022. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number	K223499 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 21, 2022
Decision Date	July 21, 2023
Days to Decision	242 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF