Cleared Traditional

DEKNATEL GWATHMEY VASCULAR STAPLING KIT (TENATIVE) (K864146) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K864146 · Cardio Thoracic Systems · General & Plastic Surgery device
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Nov 1986
Decision
14d
Days
Class 2
Risk

K864146 is an FDA 510(k) clearance for the DEKNATEL GWATHMEY VASCULAR STAPLING KIT (TENATIVE). Classified as Staple, Implantable (product code GDW), Class II - Special Controls.

Submitted by Cardio Thoracic Systems (Cupertino, US). The FDA issued a Cleared decision on November 5, 1986 after a review of 14 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 Cardio Thoracic Systems devices

Submission Details

510(k) Number K864146 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 1986
Decision Date November 05, 1986
Days to Decision 14 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 115d · This submission: 14d
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 107
Devices cleared under the same product code (GDW) and FDA review panel - the closest regulatory comparables to K864146.
TITANIUM STAPLES
K890841 · Ethicon, Inc. · Apr 1989
AUTO SUTURE ABSORBABLE FASCIA SURGICAL STAPLER*
K890270 · United States Surgical, A Division of Tyco Healthc · Mar 1989
PRECISE ILA AND ILAN SURGICAL STAPLES
K885222 · 3M Company · Feb 1989
AUTO SUTURE TITANIUM SURGICAL STAPLES
K855047 · United States Surgical, A Division of Tyco Healthc · Jan 1986
AUTO SUTURE POLY GIA SURGICAL STAPLER
K843603 · United States Surgical, A Division of Tyco Healthc · Oct 1984
DISPOSABLE LINEAR CUTTER
K843034 · Ethicon, Inc. · Sep 1984