Cleared Traditional

NEEDLETECH GUIDEWIRE INTRODUCER NEEDLE, MODELS 40021, 40069, 40053, 40042 & 40013

K031173 · Needle Tech Products, Inc. · General & Plastic Surgery

Jul 2003

Decision

100d

Days

Class 1

Risk

About This 510(k) Submission

K031173 is an FDA 510(k) clearance for the NEEDLETECH GUIDEWIRE INTRODUCER NEEDLE, MODELS 40021, 40069, 40053, 40042 & 40013, a Guide, Needle, Surgical (Class I — General Controls, product code GDF), submitted by Needle Tech Products, Inc. (Attleboro, US). The FDA issued a Cleared decision on July 23, 2003, 100 days after receiving the submission on April 14, 2003. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number	K031173 FDA.gov
FDA Decision	Cleared 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