510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K250818Substantially Equivalent

Nerveblox

Smart Alfa Teknoloji San. ve Tic. A.S., Ankara, TR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K250818 is the FDA 510(k) clearance record for Nerveblox, a class II device, cleared for Smart Alfa Teknoloji San. Ve Tic. A.S. on under FDA product code QRG (Ultrasound Guided Nerve Block Assist). FDA's definition for product code QRG reads: "This device provides real-time interpretation and enhanced visualization of live ultrasound images by highlighting anatomical landmarks in preparation for performing regional anesthesia". FDA records list 2 510(k) clearances for Smart Alfa Teknoloji San. Ve Tic. A.S., from to . As of , FDA records show no recalls naming K250818.

Clearance record

Decision date
Received
(150 days to decision)
Product code
QRG Ultrasound Guided Nerve Block Assist
Regulation
21 CFR 868.1980
Device class
Class II
Review panel
Anesthesiology
Applicant
Smart Alfa Teknoloji San. Ve Tic. A.S. Universiteler Mah. Ihsan Dogramaci Blv. No:17-1 #109, Ankara, TR
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QRG

Trailing 12 months

FDA records hold no clearances under product code QRG in the trailing twelve months.

FDA records show no clearances under product code QRG in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QRG, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260