Cleared Traditional

K003169 - VASCULAR CLOSURE DEVICE

K003169 is an FDA 510(k) clearance for VASCULAR CLOSURE DEVICE, manufactured by Std Mfg., Inc.. The device is a Class 2 General & Plastic Surgery device with product code GDW cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K003169 · Std Mfg., Inc. · General & Plastic Surgery device
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Dec 2000
Decision
59d
Days
Class 2
Risk

K003169 is an FDA 510(k) clearance for the VASCULAR CLOSURE DEVICE. Classified as Staple, Implantable (product code GDW), Class II - Special Controls.

Submitted by Std Mfg., Inc. (Stoughton, US). The FDA issued a Cleared decision on December 8, 2000 after a review of 59 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 Std Mfg., Inc. devices

FDA 510(k) Submission Details - K003169

510(k) Number K003169 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 10, 2000
Decision Date December 08, 2000
Days to Decision 59 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 115d · This submission: 59d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GDW Device Classification - Class 2, Special Controls

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 226
Devices cleared under the same product code (GDW) and FDA review panel - the closest regulatory comparables to K003169.
AUTO SUTURE SURGICAL STAPLES
K013860 · United States Surgical, A Division of Tyco Healthc · Dec 2001
SURGASSIST RIGHT ANGLE LINEAR CUTTER DLU - 45MM, MODEL RALC45
K012809 · Power Medical Interventions, Inc. · Oct 2001
AUTO SUTURE PREMIUM PLUS CEEA DISPOSABLE STAPLER
K001895 · United States Surgical, A Division of Tyco Healthc · Dec 2000
GEL MARK BIOPSY SITE MARKER, MODELS MKOOO1, MK0004, MK0007
K000060 · Senorx, Inc. · Mar 2000
ULTRACLIP TISSUE MARKER
K993785 · Inrad · Feb 2000
PROXIMATE HCS HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES
K991030 · Ethicon Endo-Surgery, Inc. · May 1999