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FDA 510(k)

NEUROSCOPE SEEG

K-Number: K861884 · 1986-10-14

ApplicantSiegen Corp.
Decision Date1986-10-14
Product CodeGWO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NEUROSCOPE SEEG is the device name listed in this FDA 510(k) record. The listed applicant is Siegen Corp.. It received FDA 510(k) clearance on 1986-10-14 under 510(k) number K861884. The device is classified under product code GWO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEUROSCOPE SEEG?

NEUROSCOPE SEEG is a medical device that received FDA 510(k) clearance on 1986-10-14. The listed applicant is Siegen Corp.. The 510(k) number is K861884.

When did NEUROSCOPE SEEG receive FDA 510(k) clearance?

NEUROSCOPE SEEG received FDA 510(k) clearance on 1986-10-14, under 510(k) number K861884.

Who is the listed applicant for NEUROSCOPE SEEG?

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

What is the FDA product code for NEUROSCOPE SEEG?

The FDA product code for NEUROSCOPE SEEG is GWO.

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 Siegen Corp. 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.

K871964SIEGEN NEUROSCOPE SEEG FOR EVOKED RESPONSE STIMU.K862430SIEGEN HEADPHONESK844616SIEGEN VISUAL STIMULATORK844646SIEGEN SURFACE ELECTRODESK843464SIEGEN NEUROSCOPE

Related Devices (Code: GWO)

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.

K262874CraniUS PlateCraniUS, LLCK261058CraniUS PlateCraniUS, LLCK250297TECHFIT Patient-Specific Cranial SystemTechfit Digital Surgery, Inc.K250334Fusion Craniofacial Implant; Fusion Skull ImplantKelyniam Global, Inc.K231834VSP PEEK Cranial Implant3D Systems, Inc.K212391MCI-Neuro Fixation SystemMci Medical Concept Innovation, Inc.

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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