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FDA 510(k)

CAROLINE GUIDE

K-Number: K981809 · 1998-08-14

ApplicantSurgical Solutions, Inc.
Decision Date1998-08-14
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

CAROLINE GUIDE is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Solutions, Inc.. It received FDA 510(k) clearance on 1998-08-14 under 510(k) number K981809. 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 CAROLINE GUIDE?

CAROLINE GUIDE is a medical device that received FDA 510(k) clearance on 1998-08-14. The listed applicant is Surgical Solutions, Inc.. The 510(k) number is K981809.

When did CAROLINE GUIDE receive FDA 510(k) clearance?

CAROLINE GUIDE received FDA 510(k) clearance on 1998-08-14, under 510(k) number K981809.

Who is the listed applicant for CAROLINE GUIDE?

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

What is the FDA product code for CAROLINE GUIDE?

The FDA product code for CAROLINE GUIDE 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 Surgical Solutions, 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.

K973277CAROLINE GUIDE/DELIA LOCALIZER

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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