Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Smoke Evacuation Fingerswitch, Smoke evacuation system with electrosurgical pencil

K-Number: K200372 · 2020-11-30

ApplicantModern Medical Equipment Manufacturing, Ltd.
Decision Date2020-11-30
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Smoke Evacuation Fingerswitch, Smoke evacuation system with electrosurgical pencil is a medical device manufactured by Modern Medical Equipment Manufacturing, Ltd.. It received FDA 510(k) clearance on 2020-11-30 under approval number K200372. 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 Smoke Evacuation Fingerswitch, Smoke evacuation system with electrosurgical pencil?

Smoke Evacuation Fingerswitch, Smoke evacuation system with electrosurgical pencil is a medical device that received FDA 510(k) clearance on 2020-11-30. It is manufactured by Modern Medical Equipment Manufacturing, Ltd.. The 510(k) number is K200372.

When was Smoke Evacuation Fingerswitch, Smoke evacuation system with electrosurgical pencil approved by the FDA?

Smoke Evacuation Fingerswitch, Smoke evacuation system with electrosurgical pencil received FDA 510(k) clearance on 2020-11-30, under approval number K200372.

What company makes Smoke Evacuation Fingerswitch, Smoke evacuation system with electrosurgical pencil?

Smoke Evacuation Fingerswitch, Smoke evacuation system with electrosurgical pencil is manufactured by Modern Medical Equipment Manufacturing, Ltd..

What is the FDA product code for Smoke Evacuation Fingerswitch, Smoke evacuation system with electrosurgical pencil?

The FDA product code for Smoke Evacuation Fingerswitch, Smoke evacuation system with electrosurgical pencil is GEI.

Related Clinical Trials

NCT07101809 Trial of Ureteroscopy vs Steerable Continuous Flow Aspiration Technology RECRUITING NCT03418402 Post Operative Pain After Laparoscopic Hysterectomy Using Airseal® Versus Standard Insufflation System COMPLETED NCT06358391 To Compare and Evaluate the Efficacy and Safety Between TS-RF System and BRK Transseptal Needles Used for Transseptal Puncture for Left Atrial Access. RECRUITING NCT06020573 Evaluation of Safety and Performance of Intraoperative Detection of Light Signals During Electrosurgical Breast Cancer Resection COMPLETED NCT07506486 Effect of Immersive Virtual Reality Cognitive Rehabilitation on Subacute Stroke Patients (A Pilot Study) NOT_YET_RECRUITING

Other Devices by Modern Medical Equipment Manufacturing, Ltd.

K192542Foot Control Electrosurgical Pencil, Push Button Electrosurgical Pencil, Rocker Switch Electrosurgical Pencil, Holster, Electorde K211170Single Use Irrigation bipolar cable K210315Single Use Hand Switch Monopolar Forceps with Smoke Evacuation, Single Use Hand Switch Bipolar Forceps with Smoke Evacuation, Single Use Hand Switch Monopolar Forceps, Single Use Hand Switch Bipolar Forceps

Related Devices (Code: GEI)

K161307NICO MyriadNico Corporation K163190InMode RF SystemInmode MD , Ltd. K163373PK AIMGyrus Acmi, Inc. K163106CODMAN Integrated Bipolar Cord and Tubing SetMedos International SARL K162676Voyant Open Fusion DeviceApplied Medical Resources K162941Ligasure Blunt Tip, Sealer/Divider, Nano-coatedCovidien

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.

↑