Cleared Traditional

BIP-COAX-SYSTEM (K915801) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K915801 · Uni-Quatro Industries Canada, Inc. · Gastroenterology & Urology device
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Mar 1994
Decision
808d
Days
Class 2
Risk

K915801 is an FDA 510(k) clearance for the BIP-COAX-SYSTEM. Classified as Biopsy Needle (product code FCG), Class II - Special Controls.

Submitted by Uni-Quatro Industries Canada, Inc. (Niagara Falls, Ontario, CA). The FDA issued a Cleared decision on March 11, 1994 after a review of 808 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1075 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all Uni-Quatro Industries Canada, Inc. devices

Submission Details

510(k) Number K915801 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 24, 1991
Decision Date March 11, 1994
Days to Decision 808 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
678d slower than avg
Panel avg: 130d · This submission: 808d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FCG Biopsy Needle
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1075
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 - FCG Biopsy Needle

All 30
Devices cleared under the same product code (FCG) and FDA review panel - the closest regulatory comparables to K915801.
INTERJECT INJECTION THERAPY NEEDLE, MODELS 1810, 1811, 1815, 1816, 1820, 1821, 1825, 1826, 1830, 1831, 1835, 1836
K012864 · Boston Scientific Corp · Oct 2001
MRI NEEDLES
K963565 · Cook, Inc. · Jul 1997
BECTON DICKINSON PRECISION CUT(TM) COAXIAL INTRODUCER NEEDLE WITH DEPTH STOP
K945813 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1995
BARD BIOPTY-CUT BIOPSY NEEDLE WITH SPACER
K910720 · C.R. Bard, Inc. · Jun 1991
MONOJECT SOFT TISSUE BIOPSY NEEDLE
K834249 · Sherwood Medical Co. · Mar 1984
MONOJECT SOFT TISSUE BIOPSY/FINE NEEDLE
K840354 · Sherwood Medical Co. · Mar 1984