Cleared Traditional

MAMMOTOME BIOPSY PROBE AND HOUSING (MAMMOTOME) (K970565) - FDA 510(k) Clearance

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

K970565 · Biopsys Medical, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1997
Decision
43d
Days
Class 2
Risk

K970565 is an FDA 510(k) clearance for the MAMMOTOME BIOPSY PROBE AND HOUSING (MAMMOTOME). Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Biopsys Medical, Inc. (Irvine, US). The FDA issued a Cleared decision on March 28, 1997 after a review of 43 days - a notably fast clearance 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: 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 Biopsys Medical, Inc. devices

Submission Details

510(k) Number K970565 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 1997
Decision Date March 28, 1997
Days to Decision 43 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
87d faster than avg
Panel avg: 130d · This submission: 43d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 96
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K970565.
AUTO SUTURE ABBI SYSTEM
K983296 · United States Surgical, A Division of Tyco Healthc · Jun 1999
THE AUTO SUTURE* MIBB** SYSTEM
K973496 · United States Surgical, A Division of Tyco Healthc · Dec 1997
QUICK-CARE BIOPSY NEEDLE
K973565 · Cook, Inc. · Nov 1997
AUTO SUTURE* ABBI* SYSTEM
K963825 · United States Surgical, A Division of Tyco Healthc · Dec 1996
SKINNY,FRANSEEN,WESCOTT NEEDLES
K962907 · Baxter Healthcare Corp · Oct 1996
BIOPSY INTRODUCER NEEDLE
K963390 · Baxter Healthcare Corp · Oct 1996