Cleared Traditional

K003297 - MAMMOTOME HAND HELD PROBE, MODEL MHH8

K003297 is an FDA 510(k) clearance for MAMMOTOME HAND HELD PROBE, manufactured by Ethicon Endo-Surgery, Inc.. The device is a Class 2 Gastroenterology & Urology device with 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

FDA 510(k) Submission Details - K003297

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.

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 211
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K003297.
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