Cleared Traditional

K895942 - GESCO DUAL LUMEN PER-Q-CATH-DL

K895942 is an FDA 510(k) clearance for GESCO DUAL LUMEN PER-Q-CATH-DL, manufactured by Gesco Intl., Inc.. The device is a Class 2 General Hospital device with product code FOZ cleared through the Traditional 510(k) pathway after a 264-day FDA review.

K895942 · Gesco Intl., Inc. · General Hospital
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Jul 1990
Decision
264d
Days
Class 2
Risk

K895942 is an FDA 510(k) clearance for the GESCO DUAL LUMEN PER-Q-CATH-DL. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Gesco Intl., Inc. (San Antonio, US). The FDA issued a Cleared decision on July 2, 1990 after a review of 264 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 - K895942

510(k) Number K895942 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 1989
Decision Date July 02, 1990
Days to Decision 264 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
135d slower than avg
Panel avg: 129d · This submission: 264d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FOZ Device Classification - Class 2, Special Controls

Product Code FOZ Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
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 - FOZ Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days

All 342
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K895942.
CATHETER WITH GUIDEWIRE ASSEMBLY DEVICE
K900056 · Abbott Laboratories · Aug 1990
MULTICATH PLACEMENT KIT
K901640 · Vygon Corp. · Aug 1990
ANTIMICROBIAL MULTI-LUMEN CENTRAL VENOUS CATHETER
K900263 · Arrow Intl., Inc. · Jul 1990
DESERET OPTIMA INTRAVASCULAR CATHETER
K900116 · Deseret Medical, Inc. · Jun 1990
DESERET INTRAVASCULAR CATHETER
K895734 · Deseret Medical, Inc. · Apr 1990
EXEL SAFELET CATHETER
K895768 · Exel Intl. · Feb 1990