Cleared Traditional

K972328 - PERCUTANEOUS BREAST BIOPSY (PBB)

K972328 is an FDA 510(k) clearance for PERCUTANEOUS BREAST BIOPSY (PBB), manufactured by Urothealth System, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNW cleared through the Traditional 510(k) pathway after a 379-day FDA review.

K972328 · Urothealth System, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1998
Decision
379d
Days
Class 2
Risk

K972328 is an FDA 510(k) clearance for the PERCUTANEOUS BREAST BIOPSY (PBB). Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Urothealth System, Inc. (Richland, US). The FDA issued a Cleared decision on July 7, 1998 after a review of 379 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Urothealth System, Inc. devices

FDA 510(k) Submission Details - K972328

510(k) Number K972328 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 1997
Decision Date July 07, 1998
Days to Decision 379 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
249d slower than avg
Panel avg: 130d · This submission: 379d
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 K972328.
TRU-CORE I REUSABLE BIOPSY INSTRUMENT
K990839 · Medical Device Technologies, Inc. · May 1999
MEICAL DEVICE TECHNOLOGIES, INC. TRU-CORE DISPOSABLE AUTOMATIC BIOPSY INSTRUMENT
K982960 · Medical Device Technologies, Inc. · Sep 1998
MEDICAL DEVICE TECHNOLOGIES, INC. TRU-CORE DISPOSALE SEMI-AUTOMATIC BIOPDY INSTRUMENT
K982085 · Medical Device Technologies, Inc. · Jul 1998
PUNCTURENEEDLE
K963794 · Ferguson Medical · Mar 1998
MANAN PRO-MAG AUTOMATIC BIOPSY SYSTEM
K980226 · Medical Device Technologies, Inc. · Feb 1998
MANAN LIVER BIOPSY KIT
K980452 · Medical Device Technologies, Inc. · Feb 1998