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)

Electrodes Handpieces for Mygen V-1000 RF System

K-Number: K193355 · 2020-08-03

ApplicantRF Medical Co., Ltd.
Decision Date2020-08-03
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Electrodes Handpieces for Mygen V-1000 RF System is the device name listed in this FDA 510(k) record. The listed applicant is RF Medical Co., Ltd.. It received FDA 510(k) clearance on 2020-08-03 under 510(k) number K193355. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Electrodes Handpieces for Mygen V-1000 RF System?

Electrodes Handpieces for Mygen V-1000 RF System is a medical device that received FDA 510(k) clearance on 2020-08-03. The listed applicant is RF Medical Co., Ltd.. The 510(k) number is K193355.

When did Electrodes Handpieces for Mygen V-1000 RF System receive FDA 510(k) clearance?

Electrodes Handpieces for Mygen V-1000 RF System received FDA 510(k) clearance on 2020-08-03, under 510(k) number K193355.

Who is the listed applicant for Electrodes Handpieces for Mygen V-1000 RF System?

The FDA 510(k) record lists RF Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Electrodes Handpieces for Mygen V-1000 RF System?

The FDA product code for Electrodes Handpieces for Mygen V-1000 RF System is GEI.

Other records listing RF Medical Co., Ltd. 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.

K232763Electrode Handpieces (VCT, RFTV, BMDT series)K221277Mygen M-3004 RF Generator M-3004K180999Mygen V-1000 RF System

Related Devices (Code: GEI)

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.

K261179AlphaTriPart - Monopolar MIC InstrumentsGimmi GmbHK253504Volnewmer™Classys, Inc.K254056THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S (TB-0535FCS); THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S (TB-0520FCS)Olympus Medical Systems Corp.K253484LUTRONIC GENIUSCynosure Lutronic Technology CorporationK251492Irrigation Tubing Bipolar Cord SetNew Deantronics Taiwan , Ltd.K260636Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coatingStryker Sustainability Solutions

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.

↑