Gesco Umbili-Cath

FDA 510(k) K911607 · Gesco Intl., Inc.

Substantially Equivalent

510(k) numberK911607

Submission

Device name
Gesco Umbili-Cath
Applicant
Gesco Intl., Inc.
San Antonio, TX, US
Received
April 10, 1991
Decision date
June 11, 1991
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
FOS – Catheter, Umbilical Artery
Device class
Class II (moderate risk)
Regulation
21 CFR 880.5200
Specialty
General Hospital

Other 510(k)s with product code FOS

510(k)DeviceApplicantDecision
K201697Umbilical Vessels CatheterFOS · Traditional Haolang Medical USA Corporation05/06/2021SE
K130725Modified Argyle Polyurethane Umbilical Vessel Catheter 2.5FR, 3.5FR, 5 Fr.FOS · Special Covidien Lp, Formerly Registered AS Kendall04/17/2013SE
K120304Footprint Medical Polyurethane Umbilical CatheterFOS · Special Footprint Medical, Inc.03/01/2012SE
K091214Footprint Medical Silicone Umbilical CatheterFOS · Traditional Footprint Medical09/25/2009SE
K091213Footprint Medical Umbilical Catheter, Dual LumenFOS · Traditional Footprint Medical09/25/2009SE
K081515Neomed Dual Lumen Umbilical Catheter, Models S2UVC4.0, S2UVC5.0FOS · Special Neomed, Inc.07/21/2008SE
K073596Neomed Single Lumen Umbilical CatheterFOS · Traditional Neomed, Inc.02/22/2008SE
K981630Vygon Double Lumen Umbilical CatheterFOS · Traditional Schiff & Co.10/01/1998SE
K963972Neo-Care Dual Lumen Umbilical CatheterFOS · Traditional Klein-Baker Medical, Inc.12/24/1996SE
K954300Argyle Neo-Sert Hydrophilic Polyurethane Umbilical Vessel Catheter Insertion TrayFOS · Traditional Sherwood Medical Co.12/13/1995SE

More from Sherwood Medical Co.

510(k)DeviceDecision
K954422Per-Q-Cath Mid-LineLJS · Traditional 12/15/1995SE
K940953Umbili-Cath-SFOS · Traditional 08/02/1994SE
K940870Umbili-CathFOS · Traditional 08/02/1994SE
K940952Umbili-Cath-S-DlFOS · Traditional 07/29/1994SE
K941672Uri-Cath CatheterGBM · Traditional 05/16/1994SE
K941232Thora-CathJOL · Traditional 05/11/1994SE
K940871Umbili-Cath-PFOS · Traditional 04/29/1994SE
K931989Ventri-CathJXG · Traditional 07/21/1993SE
K926063Per-Q-Cath Dressing Change TrayMCY · Traditional 06/07/1993SEKD
K923591Pala-NateBTR · Traditional 03/16/1993SE

Questions and answers

When was Gesco Umbili-Cath cleared by the FDA?

Gesco Umbili-Cath (K911607) received a 510(k) decision of Substantially Equivalent on June 11, 1991, 62 days after the submission was received.

What is the product code of K911607?

The FDA product code is FOS – Catheter, Umbilical Artery, a Class II (moderate risk) device regulated under 21 CFR 880.5200.