Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

OWL RF INSULATED CANNULAE

K-Number: K170708 · 2017-06-27

ApplicantDiros Technology, Inc.
Decision Date2017-06-27
Product CodeGXI
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

OWL RF INSULATED CANNULAE 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 2017-06-27 under 510(k) number K170708. 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 INSULATED CANNULAE?

OWL RF INSULATED CANNULAE is a medical device that received FDA 510(k) clearance on 2017-06-27. The listed applicant is Diros Technology, Inc.. The 510(k) number is K170708.

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

OWL RF INSULATED CANNULAE received FDA 510(k) clearance on 2017-06-27, under 510(k) number K170708.

Who is the listed applicant for OWL RF INSULATED CANNULAE?

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 INSULATED CANNULAE?

The FDA product code for OWL RF INSULATED CANNULAE is GXI.

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

View on FDA Database →

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

↑