Axostim

FDA 510(k) K883807 · Singer Medical Products, Inc.

Substantially Equivalent

510(k) numberK883807

Submission

Device name
Axostim
Applicant
Singer Medical Products, Inc.
Bensenville, IL, US
Received
September 8, 1988
Decision date
February 9, 1989
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
BXN – Stimulator, Nerve, Battery-Powered
Device class
Class II (moderate risk)
Regulation
21 CFR 868.2775
Specialty
Anesthesiology

Other 510(k)s with product code BXN

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K213049STIMPOD NMS450 Nerve StimulatorBXN · Traditional Xavant Technology (Pty), Ltd.10/16/2022SE
K162086MultiStim ECOBXN · Traditional PAJUNK GmbH Medizintechnologie01/06/2017SE
K153045SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve StimulatorBXN · Special Easy Med Instrument Co., Ltd.05/13/2016SE
K143095MiniStim MS-IVB Peripheral Nerve StimulatorBXN · Traditional Halyard Health, Inc.03/24/2015SE
K140853Stimpod ST2-3010 Nerve StimulatorBXN · Special Xavant Technology (Pty), Ltd.11/06/2014SE
K121743Easymed Peripheral Nerve Stimulator-SunstinBXN · Traditional Sunmed, LLC03/28/2013SE
K111985Myoguide System Model 8008BXN · Traditional Intronix Technologies Corp.12/30/2011SE
K110118Stimtrode Single Use Nerve StimulatorBXN · Special Xavant Technology (Pty), Ltd.02/17/2011SE
K102084Stimpod NMS450 Nerve StimulatorBXN · Traditional Xavant Technology (Pty), Ltd.12/16/2010SE
K093591Stimpod Model NMS-400 Nerve StimulatorBXN · Traditional Xavant Technology (Pty), Ltd.12/03/2009SE

More from Xavant Technology (Pty), Ltd.

510(k)DeviceDecision
K905035Axostim Nerve Stimulator, ModificationETN · Traditional 04/19/1991SE
K896909MD5 Automatic AudiometerEWO · Traditional 03/05/1990SE
K895785Audiometer Model MD-4, MD-4PEWO · Traditional 12/05/1989SE
K895784Impedance Analyzer/Audiometer Model MD-3EWO · Traditional 12/05/1989SE
K895783Impedance Analyzer Models MD-2, Md-PETY · Traditional 12/05/1989SE
K894748Impedance Anal/Screening Audiometer MD-1 & MD-1PEWO · Traditional 12/05/1989SE
K896368Modified AxostimBXN · Traditional 11/27/1989SE

Questions and answers

When was Axostim cleared by the FDA?

Axostim (K883807) received a 510(k) decision of Substantially Equivalent on February 9, 1989, 154 days after the submission was received.

What is the product code of K883807?

The FDA product code is BXN – Stimulator, Nerve, Battery-Powered, a Class II (moderate risk) device regulated under 21 CFR 868.2775.