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FDA 510(k)

OWL RF PROBES

K-Number: K110593 · 2011-05-05

ApplicantDiros Technology, Inc.
Decision Date2011-05-05
Product CodeGXI
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

OWL RF PROBES is the device name listed in this FDA 510(k) record. The listed applicant is Diros Technology, Inc.. It received FDA 510(k) clearance on 2011-05-05 under 510(k) number K110593. The device is classified under product code GXI. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OWL RF PROBES?

OWL RF PROBES is a medical device that received FDA 510(k) clearance on 2011-05-05. The listed applicant is Diros Technology, Inc.. The 510(k) number is K110593.

When did OWL RF PROBES receive FDA 510(k) clearance?

OWL RF PROBES received FDA 510(k) clearance on 2011-05-05, under 510(k) number K110593.

Who is the listed applicant for OWL RF PROBES?

The FDA 510(k) record lists Diros Technology, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OWL RF PROBES?

The FDA product code for OWL RF PROBES is GXI.

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Other records listing Diros Technology, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K170708OWL RF INSULATED CANNULAEK102566OWL CANNULAEK093185OWL UNIVERSAL RF SYSTEM URF-3AP (ML)K062758OWL URF-3APK021869OWL RADIOFREQUENCY SYSTEM, MODEL URF-2AP

Related Devices (Code: GXI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253907Disposable Radiofrequency CannulaABBOTT MEDICALK251802STAR RF Ablation SystemMerit Medical Systems, Inc.K251243OneRF Trigeminal Nerve Radiofrequency ProbesNeuroone Medical Technologies Corp.K242841Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20)ABBOTT MEDICALK250213OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit); OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Dual Kit)Stryker InstrumentsK241367RF CannulaShanghai Samedical & Plastic Instruments Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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