Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

STIMUPLEX HNS-11

K-Number: K003983 · 2001-06-06

ApplicantStockert GmbH
Decision Date2001-06-06
Product CodeBXN
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

STIMUPLEX HNS-11 is the device name listed in this FDA 510(k) record. The listed applicant is Stockert GmbH. It received FDA 510(k) clearance on 2001-06-06 under 510(k) number K003983. 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 STIMUPLEX HNS-11?

STIMUPLEX HNS-11 is a medical device that received FDA 510(k) clearance on 2001-06-06. The listed applicant is Stockert GmbH. The 510(k) number is K003983.

When did STIMUPLEX HNS-11 receive FDA 510(k) clearance?

STIMUPLEX HNS-11 received FDA 510(k) clearance on 2001-06-06, under 510(k) number K003983.

Who is the listed applicant for STIMUPLEX HNS-11?

The FDA 510(k) record lists Stockert GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STIMUPLEX HNS-11?

The FDA product code for STIMUPLEX HNS-11 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 Stockert GmbH 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.

K070336STOCKERT NEURO N50, MODEL12267K070134MODIFICATION TO STIMUPLEX HNS-12, MODEL 4892098K061983STIMUPLEX PENK052313STIMUPLEX HNS-12, MODEL 4892098

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.K110118STIMTRODE SINGLE USE NERVE STIMULATORXavant Technology (Pty), Ltd.

Official Source

View on FDA Database →

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

↑