Stimuplex HNS-11

FDA 510(k) K003983 · Stockert GmbH

Substantially Equivalent

510(k) numberK003983

Submission

Device name
Stimuplex HNS-11
Applicant
Stockert GmbH
Freiburg, DE
Received
December 26, 2000
Decision date
June 6, 2001
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

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

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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
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More from Xavant Technology (Pty), Ltd.

510(k)DeviceDecision
K070336Stockert Neuro N50, MODEL12267GXD · Traditional 06/14/2007SE
K070134Modification to Stimuplex HNS-12, Model 4892098BXN · Special 03/22/2007SE
K061983Stimuplex PenBXN · Abbreviated 11/21/2006SE
K052313Stimuplex HNS-12, Model 4892098BXN · Abbreviated 11/17/2005SE

Questions and answers

When was Stimuplex HNS-11 cleared by the FDA?

Stimuplex HNS-11 (K003983) received a 510(k) decision of Substantially Equivalent on June 6, 2001, 162 days after the submission was received.

What is the product code of K003983?

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