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FDA 510(k)

Accuro® 3S Needle Guide Kit

K-Number: K261014 · 2026-07-24

ApplicantRivanna Medical, Inc.
Decision Date2026-07-24
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Accuro® 3S Needle Guide Kit 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 K261014. 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 Accuro® 3S Needle Guide Kit?

Accuro® 3S Needle Guide Kit 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 K261014.

When did Accuro® 3S Needle Guide Kit receive FDA 510(k) clearance?

Accuro® 3S Needle Guide Kit received FDA 510(k) clearance on 2026-07-24, under 510(k) number K261014.

Who is the listed applicant for Accuro® 3S Needle Guide Kit?

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 Needle Guide Kit?

The FDA product code for Accuro® 3S Needle Guide Kit is ITX.

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.

K253452Accuro 3SK254021Accuro XVK250469Accuro® 3S Needle Guide KitK243937Accuro 3SK171594Accuro

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.

K250883ULTRASONIC PROBE UM-3R (UM-3R); ULTRASONIC PROBE UM-G20-29R (UM-G20-29R)Olympus Medical Systems CorporationK250762ULTRASONIC PROBE UM-S20-17S (UM-S20-17S); ULTRASONIC PROBE UM-S20-20R (UM-S20-20R)Olympus Medical Systems CorporationK250524Mendaera Guidance SystemMendaera, Inc.K250469Accuro® 3S Needle Guide KitRivanna Medical, Inc.K241662Ultrasound Transducer CoverVitrolife Sweden ABK233965UltraDrape UGPIV Barrier and Securement (34-15)Parker Laboratories, 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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