510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K983007Substantially Equivalent

Neurotube

Neuroregen, LLC, Bel Air MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K983007 is the FDA 510(k) clearance record for NEUROTUBE, a class II device, cleared for Neuroregen, LLC on under FDA product code JXI (Cuff, Nerve). FDA records list one 510(k) clearance for Neuroregen, LLC. As of , FDA records show one recall naming K983007.

Clearance record

Decision date
Received
(206 days to decision)
Product code
JXI Cuff, Nerve
Regulation
21 CFR 882.5275
Device class
Class II
Review panel
Neurology
Applicant
Neuroregen, LLC 43 N. Bonds St., Bel Air MD
510(k) summary
Summary
Third party review
No

Clearances, product code JXI

Trailing 12 months
2 clearances under product code JXI in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code JXI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260