Cleared Traditional

K896933 - INGRESS TECHNOLOGIES AUTO BX BIOPSY NEE...

K896933 is an FDA 510(k) clearance for INGRESS TECHNOLOGIES AUTO BX BIOPSY NEE..., manufactured by The Witmoore Group, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNW cleared through the Traditional 510(k) pathway after a 193-day FDA review.

K896933 · The Witmoore Group, Inc. · Gastroenterology & Urology device
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Jun 1990
Decision
193d
Days
Class 2
Risk

K896933 is an FDA 510(k) clearance for the INGRESS TECHNOLOGIES AUTO BX BIOPSY NEEDLE GUN. Classified as Instrument, Biopsy (product code KNW), 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

FDA 510(k) Submission Details - K896933

510(k) Number K896933 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.

KNW Device Classification - Class 2, Special Controls

Product Code KNW Instrument, Biopsy
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 - KNW Instrument, Biopsy

All 174
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K896933.
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GASTRO ENTEROLOGICAL BIOPTOME
K894419 · Symbiosis Corp. · Sep 1989
STAMEY SAMPLER SPRING LOADED BIOPSY NEEDLE
K885169 · Boston Scientific Corp · Feb 1989