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)

VIVA combo RF System (VIVA combo RF System)

K-Number: K234140 · 2024-01-30

ApplicantStarmed Co., Ltd.
Decision Date2024-01-30
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

VIVA combo RF System (VIVA combo RF System) is the device name listed in this FDA 510(k) record. The listed applicant is Starmed Co., Ltd.. It received FDA 510(k) clearance on 2024-01-30 under 510(k) number K234140. 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 VIVA combo RF System (VIVA combo RF System)?

VIVA combo RF System (VIVA combo RF System) is a medical device that received FDA 510(k) clearance on 2024-01-30. The listed applicant is Starmed Co., Ltd.. The 510(k) number is K234140.

When did VIVA combo RF System (VIVA combo RF System) receive FDA 510(k) clearance?

VIVA combo RF System (VIVA combo RF System) received FDA 510(k) clearance on 2024-01-30, under 510(k) number K234140.

Who is the listed applicant for VIVA combo RF System (VIVA combo RF System)?

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

What is the FDA product code for VIVA combo RF System (VIVA combo RF System)?

The FDA product code for VIVA combo RF System (VIVA combo RF System) is GEI.

Other records listing Starmed 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.

K252833VIVA combo RF SystemK251566TS-RF Generator (STS10)K233113ELRA Electrode (7-2B11S, 7-2B11L, 7-2B22S, 7-2B22L, 7-4B18S, 7-4B18L, 7-4B33S, 7-4B33L)K222997VVR Generator systemK203795Star RF Electrode, VIVA RF ElectrodeK181758ELRA Electrode

View all 11 devices →

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.

↑