FDA 510(k)

WYLER SUBDURAL STRIP ELECTRODE

K-Number: K850342 · 1985-07-30

ApplicantAd-Tech Medical Instrument Corp

Decision Date1985-07-30

Product CodeGYC

Advisory CommitteeNE

DecisionSubstantially Equivalent for Some Indications

Device Summary

WYLER SUBDURAL STRIP ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Ad-Tech Medical Instrument Corp. It received FDA 510(k) clearance on 1985-07-30 under 510(k) number K850342. The device is classified under product code GYC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the WYLER SUBDURAL STRIP ELECTRODE?

WYLER SUBDURAL STRIP ELECTRODE is a medical device that received FDA 510(k) clearance on 1985-07-30. The listed applicant is Ad-Tech Medical Instrument Corp. The 510(k) number is K850342.

When did WYLER SUBDURAL STRIP ELECTRODE receive FDA 510(k) clearance?

WYLER SUBDURAL STRIP ELECTRODE received FDA 510(k) clearance on 1985-07-30, under 510(k) number K850342.

Who is the listed applicant for WYLER SUBDURAL STRIP ELECTRODE?

The FDA 510(k) record lists Ad-Tech Medical Instrument Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WYLER SUBDURAL STRIP ELECTRODE?

The FDA product code for WYLER SUBDURAL STRIP ELECTRODE is GYC.

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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Ad-Tech Medical Instrument Corp as applicant

K112094BRAIN BIOPSY NEEDLE K053363DUAL-SIDED INTERHEMISPHERIC SUBDURAL ELECTRODES, GRID SUBDURAL ELECTRODES, INTRAOPERATIVE SUBDURAL ELECTRODES K053358DEPTH ELECTRODE, FORAMEN OVALE DEPTH ELECTRODES, WYLER SPHENOIDAL DEPTH ELECTRODES K041604MACRO-MICRO DEPTH ELECTRODE K990788AD-TECH'S FORAMEN OVALE ELECTRODE K992194CORTICAL MAPPING UNIT, MODEL CMU

View all 18 devices →

Related Devices (Code: GYC)

K250094Atlas Stim Headbox (NK) (31-0601-0077); Atlas Stim Headbox (Touchproof) (31-0601-0089); Atlas Stim Headbox (HD) (31-0601-0132); ASHB FIBER OPTIC DUPLEX CONN 2m (31-0204-0001); ASHB FIBER OPTIC DUPLEX CONN 7m (31-0204-0002); ATLAS Stim Headbox Software (36-0301-0006); Atlas Headbox Interface Cable (NK) (31-0204-003); Atlas Headbox Interface Cable (Touchproof) (31-0204-004); Atlas Headbox Interface Cable (HD) (31-0204-005); Atlas Headbox Expansion Panel (31-0607-0014)Neuralynx, Inc.K242618Layer 7-TPrecision Neuroscience, Corp.K221123WISE Cortical Strip (WCS)Wise S.R.L.K211954Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip and Split Grid, Intraoperative Mapping GridSpes Medica Srl K201931Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids)Dixi Medical K191346Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids)Blackrock Microsystems

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.