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FDA 510(k)

Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT Needle Tech

K-Number: K182281 · 2018-10-24

ApplicantC. R. Bard
Decision Date2018-10-24
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT Needle Tech is a medical device manufactured by C. R. Bard. It received FDA 510(k) clearance on 2018-10-24 under approval number K182281. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT Needle Tech?

Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT Needle Tech is a medical device that received FDA 510(k) clearance on 2018-10-24. It is manufactured by C. R. Bard. The 510(k) number is K182281.

When was Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT Needle Tech approved by the FDA?

Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT Needle Tech received FDA 510(k) clearance on 2018-10-24, under approval number K182281.

What company makes Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT Needle Tech?

Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT Needle Tech is manufactured by C. R. Bard.

What is the FDA product code for Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT Needle Tech?

The FDA product code for Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT Needle Tech is IYO.

Related Clinical Trials

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Related Devices (Code: IYO)

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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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