Cleared Traditional

K130873 - VWING VASCULAR NEEDLE GUIDE, 4MM X 07MM (FDA 510(k) Clearance)

Also includes:
VWING VASCULAR NEEDLE GUIDE, 6MM X 07MM VWING VASCULAR NEEDLE GUIDE, 8MM X 07M

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K130873 · Vital Access · Gastroenterology & Urology device
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Sep 2013
Decision
168d
Days
Class 2
Risk

K130873 is an FDA 510(k) clearance for the VWING VASCULAR NEEDLE GUIDE, 4MM X 07MM. Classified as Venous Window Needle Guide (product code PFH), Class II - Special Controls.

Submitted by Vital Access (Salt Lake City, US). The FDA issued a Cleared decision on September 13, 2013 after a review of 168 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5540 - the FDA gastroenterology and urology 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Vital Access devices

Submission Details

510(k) Number K130873 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 2013
Decision Date September 13, 2013
Days to Decision 168 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d slower than avg
Panel avg: 130d · This submission: 168d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PFH Venous Window Needle Guide
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5540
Definition For Use As An Access Device Accessory On Arteriovenous Fistulas (avf) For Hemodialysis Procedures Using A Constant Site Or Buttonhole Method Of Needle Insertion.
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 Gastroenterology & Urology devices follow this clearance model.