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FDA 510(k)

FRAMELESS NEUROMATE

K-Number: K991081 · 1999-06-25

ApplicantIntegrated Surgical Systems, Inc.
Decision Date1999-06-25
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

FRAMELESS NEUROMATE is the device name listed in this FDA 510(k) record. The listed applicant is Integrated Surgical Systems, Inc.. It received FDA 510(k) clearance on 1999-06-25 under 510(k) number K991081. 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 FRAMELESS NEUROMATE?

FRAMELESS NEUROMATE is a medical device that received FDA 510(k) clearance on 1999-06-25. The listed applicant is Integrated Surgical Systems, Inc.. The 510(k) number is K991081.

When did FRAMELESS NEUROMATE receive FDA 510(k) clearance?

FRAMELESS NEUROMATE received FDA 510(k) clearance on 1999-06-25, under 510(k) number K991081.

Who is the listed applicant for FRAMELESS NEUROMATE?

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

What is the FDA product code for FRAMELESS NEUROMATE?

The FDA product code for FRAMELESS NEUROMATE is HAW.

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 Integrated Surgical Systems, 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.

K072629DIGIMATCH ROBODOC SURGICAL SYSTEMK960685ORTHODOC PREOPERATIVE PLANNER MODEL 500

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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