Devices · Smart Alfa Teknoloji San. Ve Tic. A.S.

Nerveblox

Smart Alfa Teknoloji San. Ve Tic. A.S. is listed for Nerveblox (K250818). The FDA list gives August 15, 2025 as the date of the final decision. The lead panel is Anesthesiology, and the database link on the FDA list is the 510(k) pathway. openFDA describes product code QRG as “Ultrasound Guided Nerve Block Assist”: This device provides real-time interpretation and enhanced visualization of live ultrasound images by highlighting anatomical landmarks in preparation for performing regional anesthesia. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K250818

Official FDA database record

Date of final decision

August 15, 2025

Company on the FDA list

Smart Alfa Teknoloji San. Ve Tic. A.S.

Lead panel

Anesthesiology

Primary product code

QRG

openFDA device name for the code

Ultrasound Guided Nerve Block Assist

Device class

2

Regulation number

868.1980

openFDA decision description

Substantially Equivalent

openFDA decision code

SESE

Statement or summary label

Summary