Cleared Special

K013683 - MODIFICATION TO: ABBOTT VASCULAR SUTURE ANASTOMOSIS DEVICE (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K013683 · Abbott Vascular, Inc. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Dec 2001
Decision
29d
Days
Class 2
Risk

K013683 is an FDA 510(k) clearance for the MODIFICATION TO: ABBOTT VASCULAR SUTURE ANASTOMOSIS DEVICE. Classified as Suture, Nonabsorbable, Synthetic, Polypropylene (product code GAW), Class II - Special Controls.

Submitted by Abbott Vascular, Inc. (Redwood, US). The FDA issued a Cleared decision on December 6, 2001 after a review of 29 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.5010 - the FDA general and plastic surgery device 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.

View all Abbott Vascular, Inc. devices

Submission Details

510(k) Number K013683 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 2001
Decision Date December 06, 2001
Days to Decision 29 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 114d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code GAW Suture, Nonabsorbable, Synthetic, Polypropylene
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5010
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.