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FDA 510(k)

STIMTRODE SINGLE USE NERVE STIMULATOR

K-Number: K110118 · 2011-02-17

ApplicantXavant Technology (Pty), Ltd.
Decision Date2011-02-17
Product CodeBXN
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

STIMTRODE SINGLE USE NERVE STIMULATOR is the device name listed in this FDA 510(k) record. The listed applicant is Xavant Technology (Pty), Ltd.. It received FDA 510(k) clearance on 2011-02-17 under 510(k) number K110118. The device is classified under product code BXN. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STIMTRODE SINGLE USE NERVE STIMULATOR?

STIMTRODE SINGLE USE NERVE STIMULATOR is a medical device that received FDA 510(k) clearance on 2011-02-17. The listed applicant is Xavant Technology (Pty), Ltd.. The 510(k) number is K110118.

When did STIMTRODE SINGLE USE NERVE STIMULATOR receive FDA 510(k) clearance?

STIMTRODE SINGLE USE NERVE STIMULATOR received FDA 510(k) clearance on 2011-02-17, under 510(k) number K110118.

Who is the listed applicant for STIMTRODE SINGLE USE NERVE STIMULATOR?

The FDA 510(k) record lists Xavant Technology (Pty), Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STIMTRODE SINGLE USE NERVE STIMULATOR?

The FDA product code for STIMTRODE SINGLE USE NERVE STIMULATOR is BXN.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Xavant Technology (Pty), Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K213049STIMPOD NMS450 Nerve StimulatorK161091STIMPOD NMS460 Nerve StimulatorK102084STIMPOD NMS450 NERVE STIMULATORK093591STIMPOD MODEL NMS-400 NERVE STIMULATORK072092XPOD/XMAP NERVE STIMULATOR

Related Devices (Code: BXN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K213049STIMPOD NMS450 Nerve StimulatorXavant Technology (Pty), Ltd.K162086MultiStim ECOPAJUNK GmbH MedizintechnologieK153045SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve StimulatorEasy Med Instrument Co., Ltd.K121743EASYMED PERIPHERAL NERVE STIMULATOR-SUNSTINSunmed, LLCK111985MYOGUIDE SYSTEM MODEL 8008Intronix Technologies Corp.K102084STIMPOD NMS450 NERVE STIMULATORXavant Technology (Pty), Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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