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)

SENSORY NEEDLE ELECTRODE DNE 111-115,116-117,118

K-Number: K894911 · 1990-05-14

ApplicantDantec Electronics, Inc.
Decision Date1990-05-14
Product CodeGXZ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SENSORY NEEDLE ELECTRODE DNE 111-115,116-117,118 is the device name listed in this FDA 510(k) record. The listed applicant is Dantec Electronics, Inc.. It received FDA 510(k) clearance on 1990-05-14 under 510(k) number K894911. The device is classified under product code GXZ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SENSORY NEEDLE ELECTRODE DNE 111-115,116-117,118?

SENSORY NEEDLE ELECTRODE DNE 111-115,116-117,118 is a medical device that received FDA 510(k) clearance on 1990-05-14. The listed applicant is Dantec Electronics, Inc.. The 510(k) number is K894911.

When did SENSORY NEEDLE ELECTRODE DNE 111-115,116-117,118 receive FDA 510(k) clearance?

SENSORY NEEDLE ELECTRODE DNE 111-115,116-117,118 received FDA 510(k) clearance on 1990-05-14, under 510(k) number K894911.

Who is the listed applicant for SENSORY NEEDLE ELECTRODE DNE 111-115,116-117,118?

The FDA 510(k) record lists Dantec Electronics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SENSORY NEEDLE ELECTRODE DNE 111-115,116-117,118?

The FDA product code for SENSORY NEEDLE ELECTRODE DNE 111-115,116-117,118 is GXZ.

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 Dantec Electronics, Inc. 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.

K895460CONCENTRIC ELECTRODE TYPE #13R01, 13R02K884915DANTEC 22K60/61/62 CATHETER TIP TRANSDUCERK881915DANTEC MAGNETIC STIMULATORK874758DANTEC 13L40 ST. MARKS'S PUDENDAL ELECTRODEK87475913L81 DISPOSABLE SPHINCTER ELECTRODE, 13L33 CABLEK874735DANTEC 13L35/36/37 STIM. AND RECORDING ELECTRODE

View all 12 devices →

Related Devices (Code: GXZ)

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.

K241045Disposable Subdermal Needle Electrode, CorkscrewTechnomed EuropeK232581Medical Disposable Sterile Needle ElectrodeSuzhou Haishen Medical Device Associates Co., Ltd.K231691Phantom XL Insulated DilatorsTeDan Surgical Innovations, Inc.K200984Guardian Needle ElectrodeRhythmlink International, LLCK192603Spes Medica Subdermal Needle ElectrodesSpes Medica SrlK190801PressOn Electrode HeadsetRhythmlink International, LLC

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.

↑