Cleared Traditional

K913586 - MARLOW VERRES NEEDLES

K913586 is the FDA 510(k) clearance for MARLOW VERRES NEEDLES by Marlo Surgical Technology. It is a Class 2 Gastroenterology & Urology device (product code GCT) cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K913586 · Marlo Surgical Technology · Gastroenterology & Urology device
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Oct 1991
Decision
57d
Days
Class 2
Risk

K913586 is an FDA 510(k) clearance for the MARLOW VERRES NEEDLES. Classified as Light Source, Endoscope, Xenon Arc (product code GCT), Class II - Special Controls.

Submitted by Marlo Surgical Technology (Willoughby, US). The FDA issued a Cleared decision on October 8, 1991 after a review of 57 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology 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 Marlo Surgical Technology devices

Submission Details

510(k) Number K913586 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1991
Decision Date October 08, 1991
Days to Decision 57 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 130d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GCT Light Source, Endoscope, Xenon Arc
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - GCT Light Source, Endoscope, Xenon Arc

All 19
Devices cleared under the same product code (GCT) and FDA review panel - the closest regulatory comparables to K913586.
XENON ENDOSCOPIC ILLUMINATOR, MODEL XEI-300
K924897 · Medical Devices, Inc. · Jul 1993
PENTAX XENON LIGHT SOURCE
K921315 · Pentax Precision Instrument Corp. · Jun 1993
SYSTEM 3000 XENON VIDEOLAP LIGHT
K923210 · Cabot Medical Corp. · Oct 1992
ENDOSCOPIC LIGHT SOURCE
K911492 · United States Endoscopy Group, Inc. · Aug 1991
PENTEX UPPER G.I. SCOPE MODEL FG-28A
K792215 · Pentax Precision Instrument Corp. · Dec 1979