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FDA 510(k)

CLEARPOINT SYSTEM

K-Number: K100836 · 2010-06-16

ApplicantSurgivision, Inc.
Decision Date2010-06-16
Product CodeORR
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

CLEARPOINT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Surgivision, Inc.. It received FDA 510(k) clearance on 2010-06-16 under 510(k) number K100836. The device is classified under product code ORR. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CLEARPOINT SYSTEM?

CLEARPOINT SYSTEM is a medical device that received FDA 510(k) clearance on 2010-06-16. The listed applicant is Surgivision, Inc.. The 510(k) number is K100836.

When did CLEARPOINT SYSTEM receive FDA 510(k) clearance?

CLEARPOINT SYSTEM received FDA 510(k) clearance on 2010-06-16, under 510(k) number K100836.

Who is the listed applicant for CLEARPOINT SYSTEM?

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

What is the FDA product code for CLEARPOINT SYSTEM?

The FDA product code for CLEARPOINT SYSTEM is ORR.

Related Clinical Trials

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Other records listing Surgivision, 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.

K102101SURGIVISION MR COMPATIBLE VENTRICULAR CANNULAK091343MRI NEURO DRAPEK091439HEAD FIXATION ARC AND TABLE BASE

Related Devices (Code: ORR)

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.

K181195ClearPoint SystemMri Interventions, Inc.K171257ClearPoint SystemMri Interventions, Inc.K111073SURGIVISION INC. CLEARPOINT SYSTEMSurgi-Vision, Inc.

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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