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FDA 510(k)

STEALTHSTATION PASSIVE INSTRUMENT OPTION

K-Number: K972398 · 1997-09-16

ApplicantSurgical Navigation Technologies, Inc.
Decision Date1997-09-16
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

STEALTHSTATION PASSIVE INSTRUMENT OPTION is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Navigation Technologies, Inc.. It received FDA 510(k) clearance on 1997-09-16 under 510(k) number K972398. 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 STEALTHSTATION PASSIVE INSTRUMENT OPTION?

STEALTHSTATION PASSIVE INSTRUMENT OPTION is a medical device that received FDA 510(k) clearance on 1997-09-16. The listed applicant is Surgical Navigation Technologies, Inc.. The 510(k) number is K972398.

When did STEALTHSTATION PASSIVE INSTRUMENT OPTION receive FDA 510(k) clearance?

STEALTHSTATION PASSIVE INSTRUMENT OPTION received FDA 510(k) clearance on 1997-09-16, under 510(k) number K972398.

Who is the listed applicant for STEALTHSTATION PASSIVE INSTRUMENT OPTION?

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

What is the FDA product code for STEALTHSTATION PASSIVE INSTRUMENT OPTION?

The FDA product code for STEALTHSTATION PASSIVE INSTRUMENT OPTION is HAW.

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Other records listing Surgical Navigation Technologies, 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.

K000246RADIOCAMERAS EXTRACRANIAL SYSTEMK994355RADIOCAMERAS SYSTEM HEAD/NECK APPLICATIONK992461STEALTHSTATION TREATMENT GUIDANCE PLATFORMK992927STEALTHSTATION TREATMENT GUIDANCE PLATFORMK993021METRX SYSTEMK992354SNT IMAGE ANALYSIS SYSTEM

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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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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