Cleared Traditional

K973818 - T-REX BIOPSY FORCEPS

K973818 is an FDA 510(k) clearance for T-REX BIOPSY FORCEPS, manufactured by Boston Scientific Corp. The device is a Class 2 Cardiovascular device with product code DWZ cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K973818 · Boston Scientific Corp · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1997
Decision
70d
Days
Class 2
Risk

K973818 is an FDA 510(k) clearance for the 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 December 16, 1997 after a review of 70 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. 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 Boston Scientific Corp devices

FDA 510(k) Submission Details - K973818

510(k) Number K973818 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 1997
Decision Date December 16, 1997
Days to Decision 70 days
Submission Type Traditional
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
55d faster than avg
Panel avg: 125d · This submission: 70d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 15
Devices cleared under the same product code (DWZ) and FDA review panel - the closest regulatory comparables to K973818.
Biopsy Forceps
K170726 · Fehling Instruments GmbH & Co. KG · Jun 2017
MODIFICATION TO T-REX BIOPSY FORCEPS
K000409 · Boston Scientific Corp · Feb 2000
ULTRA-CBX
K991486 · Medcanica, Inc. · Nov 1999
HEARTPORT ENDOAORTIC CLAMP CATHETER
K974175 · Heartport, Inc. · Dec 1997
CORDIS BIPAL 7 /BIOPSY & BIPAL BIOPSY FORCEPS, MODIF
K933235 · Cordis Corp. · Jan 1994
CORDIS BIPAL 7 BIOPSY FORCEPS WITH A INLINE HANDLE
K932788 · Cordis Corp. · Sep 1993