Cleared Traditional

K003297 - MAMMOTOME HAND HELD PROBE

K003297 is the FDA 510(k) clearance for MAMMOTOME HAND HELD PROBE by Ethicon Endo-Surgery, Inc.. It is a Class 2 Gastroenterology & Urology device (product code KNW) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K003297 · Ethicon Endo-Surgery, Inc. · Gastroenterology & Urology device
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Jan 2001
Decision
90d
Days
Class 2
Risk

K003297 is an FDA 510(k) clearance for the MAMMOTOME HAND HELD PROBE, MODEL MHH8. Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Ethicon Endo-Surgery, Inc. (Cincinnati, US). The FDA issued a Cleared decision on January 18, 2001 after a review of 90 days - within the typical 510(k) review window.

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 Ethicon Endo-Surgery, Inc. devices

Submission Details

510(k) Number K003297 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 2000
Decision Date January 18, 2001
Days to Decision 90 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 130d · This submission: 90d
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 109
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K003297.
MAMMOTOME EX HAND HELD SYSTEM
K033700 · Ethicon Endo-Surgery, Inc. · Feb 2004
STRYKER VERTEBRAL BODY AND BONE BIOPSY KITS, STRYKER CAPTURE BODY AND BONE BIOSPSY KITS
K032943 · Stryker Corp. · Dec 2003
MAMMOTOME BIOPSY SYSTEM PROBE & HOUSING, MAMMOTOME HAND-HELD SYSTEM
K030472 · Ethicon Endo-Surgery, Inc. · Oct 2003
11 GAUGE PROBE, STEREOTACTIC, 14 GAUGE PROBE, STEREOTACTIC,14 GAUGE PROBE, ULTRASOUND, HOUSING STEREOTACTIC,HOUSING, ULT
K992813 · Ethicon Endo-Surgery, Inc. · Nov 1999
MAMMOTOME HH HAND-HELD PROBE, VACUUM SET, CONTROL MODULE, HH HAND-HELD HOLSTER AND CABLES, SOFTWARE PACKAGE, FOOTSWITCH,
K991980 · Ethicon Endo-Surgery, Inc. · Aug 1999
AUTO SUTURE ABBI SYSTEM
K983296 · United States Surgical, A Division of Tyco Healthc · Jun 1999