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FDA 510(k)

SMK SLUYTER-MEHTA CANNULAE, RF POLE, POLE,FLEXIBLE

K-Number: K870028 · 1987-10-26

ApplicantRadionics, Inc.
Decision Date1987-10-26
Product CodeGXI
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SMK SLUYTER-MEHTA CANNULAE, RF POLE, POLE,FLEXIBLE is the device name listed in this FDA 510(k) record. The listed applicant is Radionics, Inc.. It received FDA 510(k) clearance on 1987-10-26 under 510(k) number K870028. 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 SMK SLUYTER-MEHTA CANNULAE, RF POLE, POLE,FLEXIBLE?

SMK SLUYTER-MEHTA CANNULAE, RF POLE, POLE,FLEXIBLE is a medical device that received FDA 510(k) clearance on 1987-10-26. The listed applicant is Radionics, Inc.. The 510(k) number is K870028.

When did SMK SLUYTER-MEHTA CANNULAE, RF POLE, POLE,FLEXIBLE receive FDA 510(k) clearance?

SMK SLUYTER-MEHTA CANNULAE, RF POLE, POLE,FLEXIBLE received FDA 510(k) clearance on 1987-10-26, under 510(k) number K870028.

Who is the listed applicant for SMK SLUYTER-MEHTA CANNULAE, RF POLE, POLE,FLEXIBLE?

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

What is the FDA product code for SMK SLUYTER-MEHTA CANNULAE, RF POLE, POLE,FLEXIBLE?

The FDA product code for SMK SLUYTER-MEHTA CANNULAE, RF POLE, POLE,FLEXIBLE is GXI.

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Other records listing Radionics, Inc. as applicant

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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.

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