Cleared Traditional

K896041 - GESCO DUAL LUMEN UMBILICATH II-DL

K896041 is an FDA 510(k) clearance for GESCO DUAL LUMEN UMBILICATH II-DL, manufactured by Gesco Intl., Inc.. The device is a Class 2 General Hospital device with product code FOS cleared through the Traditional 510(k) pathway after a 182-day FDA review.

K896041 · Gesco Intl., Inc. · General Hospital
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Apr 1990
Decision
182d
Days
Class 2
Risk

K896041 is an FDA 510(k) clearance for the GESCO DUAL LUMEN UMBILICATH II-DL. Classified as Catheter, Umbilical Artery (product code FOS), Class II - Special Controls.

Submitted by Gesco Intl., Inc. (San Antonio, US). The FDA issued a Cleared decision on April 17, 1990 after a review of 182 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5200 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Gesco Intl., Inc. devices

FDA 510(k) Submission Details - K896041

510(k) Number K896041 FDA.gov
FDA Decision Cleared Substantially Equivalent - De Novo Granted (SEKD)
Date Received October 17, 1989
Decision Date April 17, 1990
Days to Decision 182 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
53d slower than avg
Panel avg: 129d · This submission: 182d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FOS Device Classification - Class 2, Special Controls

Product Code FOS Catheter, Umbilical Artery
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5200
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FOS Catheter, Umbilical Artery

All 22
Devices cleared under the same product code (FOS) and FDA review panel - the closest regulatory comparables to K896041.
VYGON POLYURETHANE VENOUS/ARTERIAL XRO UMBIL. CATH
K921352 · Vygon Corp. · Oct 1992
VYGON XRO VENOUS/ARTERIAL UMBILICAL CATHETER
K921374 · Vygon Corp. · Oct 1992
GESCO UMBILI-CATH
K911607 · Gesco Intl., Inc. · Jun 1991
BARD UMBILICAL VESSEL CATHETER
K890685 · C.R. Bard, Inc. · Feb 1989
ARGYLE POLYURETHANE UMBILICAL VESSEL CATHETER
K850884 · Sherwood Medical Co. · Oct 1985
XRO UMBILICAL CATHETER-CODE 270
K851005 · Vygon Corp. · May 1985