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)

Monopolar Electrode Surgical Instrument

K-Number: K230650 · 2023-10-12

ApplicantVhmed (Nantong) Co. , Ltd.
Decision Date2023-10-12
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Monopolar Electrode Surgical Instrument is the device name listed in this FDA 510(k) record. The listed applicant is Vhmed (Nantong) Co. , Ltd.. It received FDA 510(k) clearance on 2023-10-12 under 510(k) number K230650. 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 Monopolar Electrode Surgical Instrument?

Monopolar Electrode Surgical Instrument is a medical device that received FDA 510(k) clearance on 2023-10-12. The listed applicant is Vhmed (Nantong) Co. , Ltd.. The 510(k) number is K230650.

When did Monopolar Electrode Surgical Instrument receive FDA 510(k) clearance?

Monopolar Electrode Surgical Instrument received FDA 510(k) clearance on 2023-10-12, under 510(k) number K230650.

Who is the listed applicant for Monopolar Electrode Surgical Instrument?

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

What is the FDA product code for Monopolar Electrode Surgical Instrument?

The FDA product code for Monopolar Electrode Surgical Instrument is GEI.

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.

↑