Cleared Traditional

K031173 - NEEDLETECH GUIDEWIRE INTRODUCER NEEDLE

K031173 is an FDA 510(k) clearance for NEEDLETECH GUIDEWIRE INTRODUCER NEEDLE, manufactured by Needle Tech Products, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GDF cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K031173 · Needle Tech Products, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2003
Decision
100d
Days
Class 1
Risk

K031173 is an FDA 510(k) clearance for the NEEDLETECH GUIDEWIRE INTRODUCER NEEDLE, MODELS 40021, 40069, 40053, 40042 & 4.... Classified as Guide, Needle, Surgical (product code GDF), Class I - General Controls.

Submitted by Needle Tech Products, Inc. (Attleboro, US). The FDA issued a Cleared decision on July 23, 2003 after a review of 100 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Needle Tech Products, Inc. devices

FDA 510(k) Submission Details - K031173

510(k) Number K031173 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 2003
Decision Date July 23, 2003
Days to Decision 100 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
15d faster than avg
Panel avg: 115d · This submission: 100d
Pathway characteristics
Predicate-based equivalence.

GDF Device Classification - Class 1, General Controls

Product Code GDF Guide, Needle, Surgical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - GDF Guide, Needle, Surgical

All 15
Devices cleared under the same product code (GDF) and FDA review panel - the closest regulatory comparables to K031173.
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