Cleared Traditional

INGRESS TECHNOLOGIES AUTO BX BIOPSY NEEDLE (K896932) - FDA 510(k) Clearance

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

K896932 · The Witmoore Group, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1990
Decision
193d
Days
Class 2
Risk

K896932 is an FDA 510(k) clearance for the INGRESS TECHNOLOGIES AUTO BX BIOPSY NEEDLE. Classified as Biopsy Needle (product code FCG), Class II - Special Controls.

Submitted by The Witmoore Group, Inc. (Phoenix, US). The FDA issued a Cleared decision on June 22, 1990 after a review of 193 days - an extended review cycle.

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

View all The Witmoore Group, Inc. devices

Submission Details

510(k) Number K896932 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 1989
Decision Date June 22, 1990
Days to Decision 193 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
63d slower than avg
Panel avg: 130d · This submission: 193d
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 K896932.
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