FDA 510(k)

Accuro

K-Number: K171594 · 2017-10-20

Decision Date2017-10-20

Product CodeIYO

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Accuro is the device name listed in this FDA 510(k) record. The listed applicant is Rivanna Medical, LLC. It received FDA 510(k) clearance on 2017-10-20 under 510(k) number K171594. 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 Accuro?

Accuro is a medical device that received FDA 510(k) clearance on 2017-10-20. The listed applicant is Rivanna Medical, LLC. The 510(k) number is K171594.

When did Accuro receive FDA 510(k) clearance?

Accuro received FDA 510(k) clearance on 2017-10-20, under 510(k) number K171594.

Who is the listed applicant for Accuro?

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

What is the FDA product code for Accuro?

The FDA product code for Accuro is IYO.

Other records listing Rivanna Medical, LLC 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.

K261014Accuro® 3S Needle Guide Kit K253452Accuro 3S K254021Accuro XV K250469Accuro® 3S Needle Guide Kit K243937Accuro 3S

Related Devices (Code: IYO)

K253452Accuro 3SRivanna Medical, Inc.K260190ARTHURROPCA ApS K252237EdgeFlow UW20Edgecare, Inc.K254021Accuro XVRivanna Medical, Inc.K253898QT Scanner 2000 Model AQT Imaging Holdings, Inc.K253714IntraSight PlusPhilips Image Guided Therapy Corporation

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.