OWL RF INSULATED CANNULAE— 510(k) K170708

Name: FDA 510(k) clearance K170708
Creator: U.S. Food and Drug Administration
Published: 2017-06-27

Substantially Equivalent

Diros Technology, Inc.

FDA 510(k) clearance K170708 for OWL RF INSULATED CANNULAE, Substantially Equivalent on 2017-06-27. Applicant: Diros Technology, Inc.. Device class: 2.

Clearance details

Applicant: Diros Technology, Inc.
Product code: Code GXI
Device class: Class 2
Regulation: 21 CFR 882.4725
Advisory panel: Neurology
Date received: 2017-03-08
Decision date: 2017-06-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Markham, CA

Download summary PDF View on FDA.gov ↗

Recent devices under product code GXI

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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 Diros Technology, Inc.

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K150371 — Diros OWL Sterile Single Use TridentTM R.F. Insulated Cannulae,Models DTR and DTRH2015-07-30
K141586 — OWL CANNULAE2014-12-30
K102566 — OWL CANNULAE2011-06-03
K110593 — OWL RF PROBES2011-05-05
K093185 — OWL UNIVERSAL RF SYSTEM URF-3AP (ML)2010-01-22

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.