Needletech Guidewire Introducer Needle, Models 40021, 40069, 40053, 40042 & 40013

FDA 510(k) K031173 · Needle Tech Products, Inc.

Substantially Equivalent

510(k) numberK031173

Submission

Device name
Needletech Guidewire Introducer Needle, Models 40021, 40069, 40053, 40042 & 40013
Applicant
Needle Tech Products, Inc.
Attleboro, MA, US
Received
April 14, 2003
Decision date
July 23, 2003
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
GDF – Guide, Needle, Surgical
Device class
Class I (low risk)
Regulation
21 CFR 878.4800
Specialty
General, Plastic Surgery

Other 510(k)s with product code GDF

510(k)DeviceApplicantDecision
K950311Global Medical Products Brest Lesion Localization Needle with Stiffened WireGDF · Traditional Global Medical Products, Ltd.05/26/1995SE
K950007Surgical Instrument GuideGDF · Traditional United States Surgical, A Division of Tyco Healthc03/15/1995SE
K945124Breast Lesion Localization NeedleGDF · Traditional Promex, Inc.11/22/1994SE
K944942Breast Lesion Localization NeedleGDF · Traditional Promedical , Ltd.11/04/1994SE
K935538Bauer Temno Coaxial NeedleGDF · Traditional Bauer Medical, Inc.02/22/1994SE
K935457Localization Wire or Marker - SurgicalGDF · Traditional Bip USA, Inc.02/17/1994SE
K923840Needle-GrabberGDF · Traditional Guardian Angel Products, Inc.07/13/1993SE
K923835The Eleventh FingerGDF · Traditional Guardian Angel Products, Inc.07/09/1993SE
K925875Horizontal Needle Guide AttachmentGDF · Traditional Bip USA, Inc.04/06/1993SE
K924270Breast Lesion Localization NeedleGDF · Traditional Core Medical, Inc.09/23/1992SE

More from Core Medical, Inc.

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K143252Galt Tork, 0.010 to 0.020 inches (yellow), Galt Tork, 0.025 to 0.040 inches (orange)DQX · Traditional 04/23/2015SE
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Questions and answers

When was Needletech Guidewire Introducer Needle, Models 40021, 40069, 40053, 40042 & 40013 cleared by the FDA?

Needletech Guidewire Introducer Needle, Models 40021, 40069, 40053, 40042 & 40013 (K031173) received a 510(k) decision of Substantially Equivalent on July 23, 2003, 100 days after the submission was received.

What is the product code of K031173?

The FDA product code is GDF – Guide, Needle, Surgical, a Class I (low risk) device regulated under 21 CFR 878.4800.