FDA 510(k)

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

K-Number: K182281 · 2018-10-24

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 the device name listed in this FDA 510(k) record. The listed applicant is C. R. Bard. It received FDA 510(k) clearance on 2018-10-24 under 510(k) 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. The listed applicant is C. R. Bard. The 510(k) number is K182281.

When did Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT Needle Tech receive FDA 510(k) clearance?

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 510(k) number K182281.

Who is the listed applicant for Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT Needle Tech?

The FDA 510(k) record lists C. R. Bard as the applicant. This does not by itself establish the device manufacturer.

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.

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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.