Cleared Special

K000409 - MODIFICATION TO T-REX BIOPSY FORCEPS

K000409 is an FDA 510(k) clearance for MODIFICATION TO T-REX BIOPSY FORCEPS, manufactured by Boston Scientific Corp. The device is a Class 2 Cardiovascular device with product code DWZ cleared through the Special 510(k) pathway after a 20-day FDA review.

K000409 · Boston Scientific Corp · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2000
Decision
20d
Days
Class 2
Risk

K000409 is an FDA 510(k) clearance for the MODIFICATION TO T-REX BIOPSY FORCEPS. Classified as Device, Biopsy, Endomyocardial (product code DWZ), Class II - Special Controls.

Submitted by Boston Scientific Corp (Redmond, US). The FDA issued a Cleared decision on February 28, 2000 after a review of 20 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4075 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K000409

510(k) Number K000409 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 2000
Decision Date February 28, 2000
Days to Decision 20 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
105d faster than avg
Panel avg: 125d · This submission: 20d
Pathway characteristics
Modification to existing cleared device.

DWZ Device Classification - Class 2, Special Controls

Product Code DWZ Device, Biopsy, Endomyocardial
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4075
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DWZ Device, Biopsy, Endomyocardial

All 22
Devices cleared under the same product code (DWZ) and FDA review panel - the closest regulatory comparables to K000409.
Biopsy Forceps
K170726 · Fehling Instruments GmbH & Co. KG · Jun 2017
NOVATOME, MODEL: SU101-50
K072051 · Scholten Surgical Instruments, Inc. · Oct 2007
SPARROWHAWK DISPOSABLE
K010473 · Atc Technologies, Inc. · Jun 2001
ULTRA-CBX
K991486 · Medcanica, Inc. · Nov 1999
T-REX BIOPSY FORCEPS
K973818 · Boston Scientific Corp · Dec 1997
HEARTPORT ENDOAORTIC CLAMP CATHETER
K974175 · Heartport, Inc. · Dec 1997
K000409 · MODIFICATION TO T-REX BIOPSY FORCEPS
Download PDF FDA Summary Boston Scientific Corp