TOP NEUROPOLE NEEDLE, MODEL SH, BL, SC, TC— 510(k) K080771

Name: FDA 510(k) clearance K080771
Creator: U.S. Food and Drug Administration
Published: 2008-11-10

Substantially Equivalent

Top Corp.

FDA 510(k) clearance K080771 for TOP NEUROPOLE NEEDLE, MODEL SH, BL, SC, TC, Substantially Equivalent on 2008-11-10. Applicant: Top Corp.. Device class: 2.

Clearance details

Applicant: Top Corp.
Product code: Code GXI
Device class: Class 2
Regulation: 21 CFR 882.4725
Advisory panel: Neurology
Date received: 2008-03-19
Decision date: 2008-11-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dunwoody, GA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GXI

view all

K253907 — Disposable Radiofrequency Cannula2026-04-16
K251802 — STAR RF Ablation System2026-02-13
K251243 — OneRF Trigeminal Nerve Radiofrequency Probes2025-08-15
K242841 — Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20)2025-05-27
K250213 — OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit) +1 more2025-05-15

More clearances from Top Corp.

view all

Adverse events under product code GXI

product code GXI

Death: 3
Injury: 171
Total: 174

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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