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FDA 510(k)

CAROLINE GUIDE/DELIA LOCALIZER

K-Number: K973277 · 1997-11-17

ApplicantSurgical Solutions, Inc.
Decision Date1997-11-17
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

CAROLINE GUIDE/DELIA LOCALIZER 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 1997-11-17 under 510(k) number K973277. 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/DELIA LOCALIZER?

CAROLINE GUIDE/DELIA LOCALIZER is a medical device that received FDA 510(k) clearance on 1997-11-17. The listed applicant is Surgical Solutions, Inc.. The 510(k) number is K973277.

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

CAROLINE GUIDE/DELIA LOCALIZER received FDA 510(k) clearance on 1997-11-17, under 510(k) number K973277.

Who is the listed applicant for CAROLINE GUIDE/DELIA LOCALIZER?

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/DELIA LOCALIZER?

The FDA product code for CAROLINE GUIDE/DELIA LOCALIZER 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.

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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.

K981809CAROLINE GUIDE

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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