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FDA 510(k)

GOUDA FRAME FOR STEREOTACTIC NEUROSURGERY

K-Number: K852662 · 1985-08-21

ApplicantNeurosurgical Devices, Inc.
Decision Date1985-08-21
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

GOUDA FRAME FOR STEREOTACTIC NEUROSURGERY is the device name listed in this FDA 510(k) record. The listed applicant is Neurosurgical Devices, Inc.. It received FDA 510(k) clearance on 1985-08-21 under 510(k) number K852662. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GOUDA FRAME FOR STEREOTACTIC NEUROSURGERY?

GOUDA FRAME FOR STEREOTACTIC NEUROSURGERY is a medical device that received FDA 510(k) clearance on 1985-08-21. The listed applicant is Neurosurgical Devices, Inc.. The 510(k) number is K852662.

When did GOUDA FRAME FOR STEREOTACTIC NEUROSURGERY receive FDA 510(k) clearance?

GOUDA FRAME FOR STEREOTACTIC NEUROSURGERY received FDA 510(k) clearance on 1985-08-21, under 510(k) number K852662.

Who is the listed applicant for GOUDA FRAME FOR STEREOTACTIC NEUROSURGERY?

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

What is the FDA product code for GOUDA FRAME FOR STEREOTACTIC NEUROSURGERY?

The FDA product code for GOUDA FRAME FOR STEREOTACTIC NEUROSURGERY is HAW.

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Related Devices (Code: HAW)

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.

K253856Geniant Cranial (Navigated Neurosurgical Positioning Robot)Koh Young Technology, Inc.K261932Leksell® Vantage Stereotactic SystemElekta Solutions ABK253663Zeta Navigation SystemZeta Surgical, Inc.K253379Stealth AXiS Cranial clinical applicationMedtronic Navigation, Inc.K231897NeuroAlign softwareMedivis, Inc.K251317SOLOPASS 2.0 SystemIntravent Medical Partners

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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