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510(k) K250469

Accuro® 3S Needle Guide Kit by Rivanna Medical, Inc. — Product Code ITX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 13, 2025
Date Received
February 18, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transducer, Ultrasonic, Diagnostic
Device Class
Class II
Regulation Number
892.1570
Review Panel
RA
Submission Type

Other clearances by Rivanna Medical, Inc.

  • K243937 — Accuro 3S (May 23, 2025)
  • K171594 — Accuro (October 20, 2017)
  • K132736 — ACCURO 3000 ULTRASOUND SCANNER (March 11, 2014)

Other clearances for product code ITX

  • K250883 — ULTRASONIC PROBE UM-3R (UM-3R); ULTRASONIC PROBE UM-G20-29R (UM-G20-29R) (September 18, 2025)
  • K250762 — ULTRASONIC PROBE UM-S20-17S (UM-S20-17S); ULTRASONIC PROBE UM-S20-20R (UM-S20-20 (July 11, 2025)
  • K250524 — Mendaera Guidance System (July 2, 2025)
  • K241662 — Ultrasound Transducer Cover (August 30, 2024)
  • K233965 — UltraDrape UGPIV Barrier and Securement (34-15) (August 15, 2024)
  • K241615 — Transducer Probe Cover (July 3, 2024)
  • K233109 — TP Pivot Pro™ Needle Guide (December 22, 2023)
  • K231666 — Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L) (December 13, 2023)
  • K231783 — VitroPRO (November 14, 2023)
  • K223689 — Disposable Needle Guides and Grids (August 2, 2023)