NEUROTUBE— 510(k) K983007

Substantially Equivalent

Neuroregen, LLC

FDA 510(k) clearance K983007 for NEUROTUBE, Substantially Equivalent on 1999-03-22. Applicant: Neuroregen, LLC. Device class: 2.

Clearance details

Applicant: Neuroregen, LLC
Product code: Code JXI
Device class: Class 2
Regulation: 21 CFR 882.5275
Advisory panel: Neurology
Date received: 1998-08-28
Decision date: 1999-03-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bel Air, MD, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JXI

K260245 — SILKBridge2026-04-09
K253363 — NeuroSpan Bridge2026-01-17
K251505 — VersaCoat Nerve Protector (VTP-44G2); VersaCoat Nerve Protector (VTP-12G1)2025-07-22
K251175 — VersaWrap Nerve Protector (VTP-2201); VersaWrap Nerve Protector (VTP-1201)2025-07-17
K242113 — Nerve Wrap (07-DW-001-TAB)2025-04-02

Recalls naming K983007

K-number listed on FDA's recall record

Z-1461-2023 — GEM NEUROTUBE, Absorbable Woven Polyglycolic Acid Mesh Tube, Product Codes: a) 5311-01240-010, b) 5311-01240-012; for peripheral nerve repairClass II·Ongoing·Baxter Healthcare Corporation·20230327

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K983007.

Data sourced from openFDA. This site is unofficial and independent of the FDA.