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FDA 510(k)

SURGIVISION INC. CLEARPOINT SYSTEM

K-Number: K111073 · 2011-06-22

ApplicantSurgi-Vision, Inc.
Decision Date2011-06-22
Product CodeORR
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SURGIVISION INC. CLEARPOINT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Surgi-Vision, Inc.. It received FDA 510(k) clearance on 2011-06-22 under 510(k) number K111073. 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 SURGIVISION INC. CLEARPOINT SYSTEM?

SURGIVISION INC. CLEARPOINT SYSTEM is a medical device that received FDA 510(k) clearance on 2011-06-22. The listed applicant is Surgi-Vision, Inc.. The 510(k) number is K111073.

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

SURGIVISION INC. CLEARPOINT SYSTEM received FDA 510(k) clearance on 2011-06-22, under 510(k) number K111073.

Who is the listed applicant for SURGIVISION INC. CLEARPOINT SYSTEM?

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

What is the FDA product code for SURGIVISION INC. CLEARPOINT SYSTEM?

The FDA product code for SURGIVISION INC. CLEARPOINT SYSTEM is ORR.

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Other records listing Surgi-Vision, 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.

K020790INTERCEPT ESOPHAGEAL INTERNAL MR COIL, INTERCEPT URETHRAL MICROCOIL, AND INTERCEPT VASCULAR INTERNAL MR COILK020495INTERCEPT ESOPHAGEAL INTERNAL MR COIL, INTERCEPT URETHRAL INTERNAL MR COIL, AND INTERCEPT VASCULAR INTERNAL MR COILK011781INTERCEPT-URETHRAL MICROCOILK003436SURGI-VISION GUIDEWIRE COILK002916SURGI-VISION PROSTATE COILK002345SURGI-VISION URETHRAL COIL

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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.K100836CLEARPOINT SYSTEMSurgivision, Inc.

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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