Cleared Traditional

K033700 - MAMMOTOME EX HAND HELD SYSTEM (FDA 510(k) Clearance)

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

K033700 · Ethicon Endo-Surgery, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2004
Decision
87d
Days
Class 2
Risk

K033700 is an FDA 510(k) clearance for the MAMMOTOME EX HAND HELD SYSTEM. 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 February 20, 2004 after a review of 87 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 Ethicon Endo-Surgery, Inc. devices

Submission Details

510(k) Number K033700 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 2003
Decision Date February 20, 2004
Days to Decision 87 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
43d faster than avg
Panel avg: 130d · This submission: 87d
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 360
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K033700.
Promisemed VeriEcto Automatic Biopsy Needles
K261196 · Promisemed Hangzhou Meditech Co., Ltd. · May 2026
Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Control Module
K260365 · Devicor Medical Products, Inc. · Mar 2026
ZeniCore™ Automatic Biopsy Instrument (863212100 / ZeniCore Automatic Biopsy Device 12ga x 10cm with Coaxial Introducer Kit)
K252795 · Argon Medical Devices, Inc. · Feb 2026
EnCor EnCompass™ Breast Biopsy and Tissue Removal System
K252681 · Bard Peripheral Vascular, Inc. · Dec 2025
Resitu Slider 09 (RESL09)
K252183 · Resitu Medical AB · Sep 2025
Forcyte Autograft Harvest Kit
K243407 · Forcyte Medical, LLC · Jul 2025