Cleared Traditional

Rebuilder Nerve Guidance Conduit

K230794 · Celestray Biotech Company, LLC., · Neurology

Jan 2024

Decision

313d

Days

Class 2

Risk

About This 510(k) Submission

K230794 is an FDA 510(k) clearance for the Rebuilder Nerve Guidance Conduit, a Cuff, Nerve (Class II — Special Controls, product code JXI), submitted by Celestray Biotech Company, LLC., (Bethesda, US). The FDA issued a Cleared decision on January 29, 2024, 313 days after receiving the submission on March 22, 2023. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5275.

Submission Details

510(k) Number	K230794 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 22, 2023
Decision Date	January 29, 2024
Days to Decision	313 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF