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FDA 510(k)

ULTRASOUND GENERAL PURPOSE GUIDANCE SYSTEM

K-Number: K093713 · 2010-01-19

ApplicantCivco Medical Instruments
Decision Date2010-01-19
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ULTRASOUND GENERAL PURPOSE GUIDANCE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Civco Medical Instruments. It received FDA 510(k) clearance on 2010-01-19 under 510(k) number K093713. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRASOUND GENERAL PURPOSE GUIDANCE SYSTEM?

ULTRASOUND GENERAL PURPOSE GUIDANCE SYSTEM is a medical device that received FDA 510(k) clearance on 2010-01-19. The listed applicant is Civco Medical Instruments. The 510(k) number is K093713.

When did ULTRASOUND GENERAL PURPOSE GUIDANCE SYSTEM receive FDA 510(k) clearance?

ULTRASOUND GENERAL PURPOSE GUIDANCE SYSTEM received FDA 510(k) clearance on 2010-01-19, under 510(k) number K093713.

Who is the listed applicant for ULTRASOUND GENERAL PURPOSE GUIDANCE SYSTEM?

The FDA 510(k) record lists Civco Medical Instruments as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ULTRASOUND GENERAL PURPOSE GUIDANCE SYSTEM?

The FDA product code for ULTRASOUND GENERAL PURPOSE GUIDANCE SYSTEM is ITX.

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Related Devices (Code: ITX)

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.

K260114Align® Cover and Pad Guidance ToolCIVCO Medical Instruments Co., Inc.K261170BA-004CCFujifilm CorporationK254143EM-TECH Passive Ultrasound Probe StrapEM-TECH Solutions, Inc.K260161SmartGuide Disposable Guides and GridsUC-CARE , Ltd.K262474ND Needle Guidance SystemAccurate Access, LLCK261014Accuro® 3S Needle Guide KitRivanna Medical, 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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