Hawkins Breast Localization Needle

FDA 510(k) K870523 · N-S Medical Products

Substantially Equivalent

510(k) numberK870523

Submission

Device name
Hawkins Breast Localization Needle
Applicant
N-S Medical Products
Gainesville, FL, US
Received
February 6, 1987
Decision date
March 9, 1987
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
GDM – Needle, Aspiration And Injection, Reusable
Device class
Class I (low risk)
Regulation
21 CFR 878.4800
Specialty
General, Plastic Surgery

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K071732MarrowminerGDM · Traditional Stemcor Systems, Inc.09/24/2007SE
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K953082Iliac Crest Bone Marrow Aspiration NeedleGDM · Traditional Baxter Healthcare Corp09/22/1995SE
K953064Bioaccess Marrow Harvest SystemGDM · Traditional Bioaccess, Inc.08/07/1995SE
K936207Endo-Needle InstrumentGDM · Traditional Gerard Medical, Inc.06/16/1994SE
K930160Illinois Sternal/Iliac Aspiration NeedleGDM · Traditional Symbiosis Corp.07/06/1993SE
K923872Bone Marrow Biopsy SystemGDM · Traditional The Straumann Co.12/15/1992SE
K915572Becton Dickinson Modified Menghini NeedleGDM · Traditional Bd Becton Dickinson Vacutainer Systems Preanalytic02/03/1992SE
K904667Na NeedlesGDM · Traditional Olympus Corp.12/12/1990SE
K903750Islam Sternal Puncture Needle, Cat #AG-598-OO-EGDM · Traditional Downs Surgical , Ltd.10/31/1990SE

More from Downs Surgical , Ltd.

510(k)DeviceDecision
K880288Tru-Trac Torque GuidewireDQX · Traditional 09/12/1988SE
K880287Tru-Trac Coiled GuidewireDQX · Traditional 09/12/1988SE
K881957Hawkins-Akins Blunt Needle Access KitKNW · Traditional 05/20/1988SE
K881956National-Standard Needle HolderKNW · Traditional 05/20/1988SE

Questions and answers

When was Hawkins Breast Localization Needle cleared by the FDA?

Hawkins Breast Localization Needle (K870523) received a 510(k) decision of Substantially Equivalent on March 9, 1987, 31 days after the submission was received.

What is the product code of K870523?

The FDA product code is GDM – Needle, Aspiration And Injection, Reusable, a Class I (low risk) device regulated under 21 CFR 878.4800.