Cleared Traditional

K911607 - GESCO UMBILI-CATH

K911607 is an FDA 510(k) clearance for GESCO UMBILI-CATH, 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 62-day FDA review.

K911607 · Gesco Intl., Inc. · General Hospital
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Jun 1991
Decision
62d
Days
Class 2
Risk

K911607 is an FDA 510(k) clearance for the GESCO UMBILI-CATH. 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 June 11, 1991 after a review of 62 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Gesco Intl., Inc. devices

FDA 510(k) Submission Details - K911607

510(k) Number K911607 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 1991
Decision Date June 11, 1991
Days to Decision 62 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
67d faster than avg
Panel avg: 129d · This submission: 62d
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 K911607.
UMBILI-CATH-P
K940871 · Gesco Intl., Inc. · Apr 1994
VYGON POLYURETHANE VENOUS/ARTERIAL XRO UMBIL. CATH
K921352 · Vygon Corp. · Oct 1992
VYGON XRO VENOUS/ARTERIAL UMBILICAL CATHETER
K921374 · Vygon Corp. · Oct 1992
GESCO DUAL LUMEN UMBILICATH II-DL
K896041 · Gesco Intl., Inc. · Apr 1990
BARD UMBILICAL VESSEL CATHETER
K890685 · C.R. Bard, Inc. · Feb 1989
ARGYLE POLYURETHANE UMBILICAL VESSEL CATHETER
K850884 · Sherwood Medical Co. · Oct 1985