Cleared Traditional

K033700 - MAMMOTOME EX HAND HELD SYSTEM

K033700 is an FDA 510(k) clearance for MAMMOTOME EX HAND HELD SYSTEM, 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 87-day FDA review.

K033700 · Ethicon Endo-Surgery, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K033700

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 131d · This submission: 87d
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 365
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K033700.
SENORX BIOPSY DEVICE II
K040842 · Senorx, Inc. · Apr 2004
RABBIT
K040087 · Scion International, Inc. · Apr 2004
TRAPMATIC SYSTEM SET
K033616 · H.S Hospital Service S.P.A · Mar 2004
STRYKER VERTEBRAL BODY AND BONE BIOPSY KITS, STRYKER CAPTURE BODY AND BONE BIOSPSY KITS
K032943 · Stryker Corp. · Dec 2003
MODIFICATION TO EN-BLOC BIOPSY SYSTEM
K033427 · Neothermia Corp. · Nov 2003
MAMMOTOME BIOPSY SYSTEM PROBE & HOUSING, MAMMOTOME HAND-HELD SYSTEM
K030472 · Ethicon Endo-Surgery, Inc. · Oct 2003
K033700 · MAMMOTOME EX HAND HELD SYSTEM
Download PDF FDA Summary Ethicon Endo-Surgery,…