FDA 510(k)

Accuro 3S

K-Number: K253452 · 2026-07-24

Decision Date2026-07-24

Product CodeIYO

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Accuro 3S is the device name listed in this FDA 510(k) record. The listed applicant is Rivanna Medical, Inc.. It received FDA 510(k) clearance on 2026-07-24 under 510(k) number K253452. 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 3S?

Accuro 3S is a medical device that received FDA 510(k) clearance on 2026-07-24. The listed applicant is Rivanna Medical, Inc.. The 510(k) number is K253452.

When did Accuro 3S receive FDA 510(k) clearance?

Accuro 3S received FDA 510(k) clearance on 2026-07-24, under 510(k) number K253452.

Who is the listed applicant for Accuro 3S?

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

What is the FDA product code for Accuro 3S?

The FDA product code for Accuro 3S is IYO.

Other records listing Rivanna Medical, 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.

K261014Accuro® 3S Needle Guide Kit K254021Accuro XV K250469Accuro® 3S Needle Guide Kit K243937Accuro 3S K171594Accuro

Related Devices (Code: IYO)

K260190ARTHURROPCA ApS K252237EdgeFlow UW20Edgecare, Inc.K254021Accuro XVRivanna Medical, Inc.K253898QT Scanner 2000 Model AQT Imaging Holdings, Inc.K253714IntraSight PlusPhilips Image Guided Therapy Corporation K253221Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro)Eieling Technology (Shenzhen) Limited

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.