Cleared Traditional

K032973 - REPROCESSED DISPOSABLE CUTTERS

K032973 is the FDA 510(k) clearance for REPROCESSED DISPOSABLE CUTTERS by Vanguard Medical Concepts, Inc.. It is a Class 2 General & Plastic Surgery device (product code GDW) cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K032973 · Vanguard Medical Concepts, Inc. · General & Plastic Surgery device
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Dec 2003
Decision
85d
Days
Class 2
Risk

K032973 is an FDA 510(k) clearance for the REPROCESSED DISPOSABLE CUTTERS, STAPLERS AND APPLIERS. Classified as Staple, Implantable (product code GDW), Class II - Special Controls.

Submitted by Vanguard Medical Concepts, Inc. (Lubbock, US). The FDA issued a Cleared decision on December 18, 2003 after a review of 85 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4750 - the FDA general and plastic surgery 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 Vanguard Medical Concepts, Inc. devices

Submission Details

510(k) Number K032973 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2003
Decision Date December 18, 2003
Days to Decision 85 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 115d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GDW Staple, Implantable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4750
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GDW Staple, Implantable

All 159
Devices cleared under the same product code (GDW) and FDA review panel - the closest regulatory comparables to K032973.
PROXIMATE PPH HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES
K051301 · Ethicon Endo-Surgery, Inc. · Aug 2005
ENDOPATH ENDOCUTTER 60 ENDOSCOPIC LINEAR CUTTER
K051002 · Ethicon Endo-Surgery, Inc. · May 2005
CURVED CUTTER STAPLER, MODELS CS40B, CS40G
K040038 · Ethicon Endo-Surgery, Inc. · Feb 2004
AUTO SUTURE ENDOSCOPIC (& OPEN) TA SURGICAL STAPLER, AUTO SUTURE ENDOSCOPIC (& OPEN) GIA SURGICAL STAPLING INSTRUMENT
K032696 · United States Surgical, A Division of Tyco Healthc · Dec 2003
PROXIMATE HCS HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES, MODEL PPH01
K030925 · Ethicon Endo-Surgery, Inc. · May 2003
PROXIMATE PPH HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES, MODEL PPH03
K030411 · Ethicon Endo-Surgery, Inc. · Mar 2003