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FDA 510(k)

ILOOK 25 NEEDLE GUIDE ATTACHMENT AND BRACKET ASSEMBLY

K-Number: K030064 · 2003-01-22

ApplicantSonosite,Inc.
Decision Date2003-01-22
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ILOOK 25 NEEDLE GUIDE ATTACHMENT AND BRACKET ASSEMBLY is the device name listed in this FDA 510(k) record. The listed applicant is Sonosite,Inc.. It received FDA 510(k) clearance on 2003-01-22 under 510(k) number K030064. 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 ILOOK 25 NEEDLE GUIDE ATTACHMENT AND BRACKET ASSEMBLY?

ILOOK 25 NEEDLE GUIDE ATTACHMENT AND BRACKET ASSEMBLY is a medical device that received FDA 510(k) clearance on 2003-01-22. The listed applicant is Sonosite,Inc.. The 510(k) number is K030064.

When did ILOOK 25 NEEDLE GUIDE ATTACHMENT AND BRACKET ASSEMBLY receive FDA 510(k) clearance?

ILOOK 25 NEEDLE GUIDE ATTACHMENT AND BRACKET ASSEMBLY received FDA 510(k) clearance on 2003-01-22, under 510(k) number K030064.

Who is the listed applicant for ILOOK 25 NEEDLE GUIDE ATTACHMENT AND BRACKET ASSEMBLY?

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

What is the FDA product code for ILOOK 25 NEEDLE GUIDE ATTACHMENT AND BRACKET ASSEMBLY?

The FDA product code for ILOOK 25 NEEDLE GUIDE ATTACHMENT AND BRACKET ASSEMBLY is ITX.

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Other records listing Sonosite,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.

K113156SONOSITE EDGE ULTRASOUND SYSTEMK110645BIO Z CARDIO PROFILE HEMODYNAMIC MONITORK102390SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEMK093510LUMENVU CATHETER GUIDANCE SYSTEMK101757SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEM, SONOSITE MAXX SERIES ULTRASOUND SYSTEMK092058SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEM

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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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