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FDA 510(k)

COMPASS(TM) STEREOTACTIC RETRACTOR SYSTEM

K-Number: K896156 · 1989-12-06

ApplicantStereotactic Medical Systems, Inc.
Decision Date1989-12-06
Product CodeGZT
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

COMPASS(TM) STEREOTACTIC RETRACTOR SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Stereotactic Medical Systems, Inc.. It received FDA 510(k) clearance on 1989-12-06 under 510(k) number K896156. The device is classified under product code GZT. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COMPASS(TM) STEREOTACTIC RETRACTOR SYSTEM?

COMPASS(TM) STEREOTACTIC RETRACTOR SYSTEM is a medical device that received FDA 510(k) clearance on 1989-12-06. The listed applicant is Stereotactic Medical Systems, Inc.. The 510(k) number is K896156.

When did COMPASS(TM) STEREOTACTIC RETRACTOR SYSTEM receive FDA 510(k) clearance?

COMPASS(TM) STEREOTACTIC RETRACTOR SYSTEM received FDA 510(k) clearance on 1989-12-06, under 510(k) number K896156.

Who is the listed applicant for COMPASS(TM) STEREOTACTIC RETRACTOR SYSTEM?

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

What is the FDA product code for COMPASS(TM) STEREOTACTIC RETRACTOR SYSTEM?

The FDA product code for COMPASS(TM) STEREOTACTIC RETRACTOR SYSTEM is GZT.

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 Stereotactic Medical 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.

K884415EP-100 (SERIES)K883653EP-100 INFUSION PUMPK871046COMPASS STEREOTACTIC POSITIONING SYSTEMK862220COMPASS CT STEREOTACTIC ADAPTATION SYSTEM

Related Devices (Code: GZT)

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.

K252995Durashield Device KitSurGenTec, LLCK210615Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull Clamp Mounted (SCM)Thompson Surgical Instruments, Inc.K202694Vycor Medical Viewsite Brain Access System (“VBAS”) and VBAS with Alignment Clip (“VBAS AC”) (together the “VBAS Family”)Vycor Medical, Inc.K202072MindsEye Expandable PortMinnetronix Neuro, Inc.K180610Geister retractor for neuro - and spine surgeryGeister Medizin Technik GmbHK172433NICO BrainPathNico Corporation

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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