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510(k) K250818

Nerveblox by Smart Alfa Teknoloji San. Ve Tic. A.S. — Product Code QRG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 15, 2025
Date Received
March 18, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ultrasound Guided Nerve Block Assist
Device Class
Class II
Regulation Number
868.1980
Review Panel
AN
Submission Type

This device provides real-time interpretation and enhanced visualization of live ultrasound images by highlighting anatomical landmarks in preparation for performing regional anesthesia.

Other clearances for product code QRG

  • K232787 — ScanNav Anatomy Peripheral Nerve Block (October 6, 2023)
  • DEN220024 — ScanNav Anatomy Peripheral Nerve Block (October 18, 2022)