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FDA 510(k)

MultiGen™ 2 RF Generator System

K-Number: K170242 · 2017-05-25

ApplicantStryker Corporation
Decision Date2017-05-25
Product CodeGXD
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MultiGen™ 2 RF Generator System is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Corporation. It received FDA 510(k) clearance on 2017-05-25 under 510(k) number K170242. The device is classified under product code GXD. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MultiGen™ 2 RF Generator System?

MultiGen™ 2 RF Generator System is a medical device that received FDA 510(k) clearance on 2017-05-25. The listed applicant is Stryker Corporation. The 510(k) number is K170242.

When did MultiGen™ 2 RF Generator System receive FDA 510(k) clearance?

MultiGen™ 2 RF Generator System received FDA 510(k) clearance on 2017-05-25, under 510(k) number K170242.

Who is the listed applicant for MultiGen™ 2 RF Generator System?

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

What is the FDA product code for MultiGen™ 2 RF Generator System?

The FDA product code for MultiGen™ 2 RF Generator System is GXD.

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Related Devices (Code: GXD)

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.

K251247GX1 Radiofrequency Generator Kit (RFG-X1-120V); GX1 Radiofrequency Generator Kit (RFG-X1-220V); GX1 Radiofrequency Generator Kit (RFG-X1-240V); GX1 System Release Rest of World (GX1-SYS-ROW); GX1 Radiofrequency Generator (51779845-01); GX1 Radiofrequency Generator (51779845-02); GX1 Radiofrequency Generator (51779845-03)Boston Scientific Neuromodulation CorporationK242057COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R)Avanos Medical, Inc.K232632Racz Neurostat RF GeneratorEpimed InternationalK231675OneRF Ablation SystemNeuroone Medical Technologies Corp.K220122APEX 6Rf Innovations, Inc.K203293Abbott Medical Grounding Pad, model RF-DGP-ISABBOTT MEDICAL

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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