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FDA 510(k)

NEUROMATE STEREOTACTIC SYSTEM

K-Number: K963256 · 1997-05-09

ApplicantIntegrated Surgical Systems, S.A.
Decision Date1997-05-09
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NEUROMATE STEREOTACTIC SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Integrated Surgical Systems, S.A.. It received FDA 510(k) clearance on 1997-05-09 under 510(k) number K963256. 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 NEUROMATE STEREOTACTIC SYSTEM?

NEUROMATE STEREOTACTIC SYSTEM is a medical device that received FDA 510(k) clearance on 1997-05-09. The listed applicant is Integrated Surgical Systems, S.A.. The 510(k) number is K963256.

When did NEUROMATE STEREOTACTIC SYSTEM receive FDA 510(k) clearance?

NEUROMATE STEREOTACTIC SYSTEM received FDA 510(k) clearance on 1997-05-09, under 510(k) number K963256.

Who is the listed applicant for NEUROMATE STEREOTACTIC SYSTEM?

The FDA 510(k) record lists Integrated Surgical Systems, S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NEUROMATE STEREOTACTIC SYSTEM?

The FDA product code for NEUROMATE STEREOTACTIC SYSTEM 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.

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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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