LS9000 Suction Biopsy Needle

FDA 510(k) K862749 · Engineering, Inc.

Substantially Equivalent

510(k) numberK862749

Submission

Device name
LS9000 Suction Biopsy Needle
Applicant
Engineering, Inc.
Foster City, CA, US
Received
July 21, 1986
Decision date
September 15, 1986
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

Other 510(k)s with product code GDM

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K071732MarrowminerGDM · Traditional Stemcor Systems, Inc.09/24/2007SE
K971114Bioaccess Marrow Harvest SystemGDM · Traditional Bioaccess, Inc.06/03/1997SE
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
K881521Modified Servo SyringeDXT · Traditional 05/31/1988SE
K862476LS3000 Cannula Uterine SuctionHHI · Traditional 07/18/1986SE
K854359LM2000A Surgical Suction MonitorKDQ · Traditional 03/03/1986SE
K854844LS1000 Surgical Aspirator IIBTA · Traditional 02/12/1986SN

Questions and answers

When was LS9000 Suction Biopsy Needle cleared by the FDA?

LS9000 Suction Biopsy Needle (K862749) received a 510(k) decision of Substantially Equivalent on September 15, 1986, 56 days after the submission was received.

What is the product code of K862749?

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