Jackson Fine Needle Aspiration System

FDA 510(k) K896606 · National-Standard Medical Products

Substantially Equivalent

510(k) numberK896606

Submission

Device name
Jackson Fine Needle Aspiration System
Applicant
National-Standard Medical Products
Gainesville, FL, US
Received
November 21, 1989
Decision date
January 4, 1990
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

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

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K011586Irma SL Blood Analysis System GL CartridgeGAA · Traditional Diametrics Medical, Inc.11/16/2001SE
K994151Percutx-Injection/Aspiration Needle Probes/DevicesGAA · Traditional Ximed/Prosure/Injectx03/01/2000SE
K983200Injection/Aspiration Needles Probes/Devices-Tpi/Tpi FlexGAA · Traditional Ximed/Prosure/Injectx12/11/1998SE
K974741Manan Accura NeedleGAA · Traditional Medical Device Technologies, Inc.01/08/1998SE
K962425Bonopty Coaxial Bone Biopsy System with Eccentric DRILL(10-1072,3,4)GAA · Traditional Radi Medical Systems AB09/11/1996SE
K961959MD Tech Biopsy Set for Bone and Bone MarrowGAA · Traditional Medical Device Technologies, Inc.07/19/1996SE
K945109Monoject Bone Marrow Biopsy TraysGAA · Traditional Sherwood Medical Co.11/14/1994SE
K940025Manan Bone Marrow Harvest NeedlesGAA · Traditional Manan Medical Products, Inc.02/25/1994SE

More from Manan Medical Products, Inc.

510(k)DeviceDecision
K900822Hydro-Sil(Tm) Coated GuidewiresDOX · Traditional 07/17/1990SE
K896605Kopans Stabilized Needle Aspiration Guide (Snag)GAA · Traditional 01/04/1990SE

Questions and answers

When was Jackson Fine Needle Aspiration System cleared by the FDA?

Jackson Fine Needle Aspiration System (K896606) received a 510(k) decision of Substantially Equivalent on January 4, 1990, 44 days after the submission was received.

What is the product code of K896606?

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