FDA 510(k)

BOVIE ICON VS GENERAL PURPOSE RF GENERATOR, MODEL: VS300

K-Number: K092383 · 2010-03-10

Decision Date2010-03-10

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

BOVIE ICON VS GENERAL PURPOSE RF GENERATOR, MODEL: VS300 is the device name listed in this FDA 510(k) record. The listed applicant is Bovie Medical Corporation. It received FDA 510(k) clearance on 2010-03-10 under 510(k) number K092383. 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 BOVIE ICON VS GENERAL PURPOSE RF GENERATOR, MODEL: VS300?

BOVIE ICON VS GENERAL PURPOSE RF GENERATOR, MODEL: VS300 is a medical device that received FDA 510(k) clearance on 2010-03-10. The listed applicant is Bovie Medical Corporation. The 510(k) number is K092383.

When did BOVIE ICON VS GENERAL PURPOSE RF GENERATOR, MODEL: VS300 receive FDA 510(k) clearance?

BOVIE ICON VS GENERAL PURPOSE RF GENERATOR, MODEL: VS300 received FDA 510(k) clearance on 2010-03-10, under 510(k) number K092383.

Who is the listed applicant for BOVIE ICON VS GENERAL PURPOSE RF GENERATOR, MODEL: VS300?

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

What is the FDA product code for BOVIE ICON VS GENERAL PURPOSE RF GENERATOR, MODEL: VS300?

The FDA product code for BOVIE ICON VS GENERAL PURPOSE RF GENERATOR, MODEL: VS300 is GEI.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Bovie Medical Corporation as applicant

K183610Renuvion/J-Plasma Precise Handpiece, Renuvion/J-Plasma Precise Open handpieces, Renuvion/J-Plasma Precise Open handpieces K170777Bovie J-Plasma Precise FLEX Handpiece K170188Bovie J-Plasma Precise Open handpiece & Bovie Ultimate Gen 2 High Frequency Electrosurgical Generator K161558Bovie 3.3mm Disposable Bipolar Ablator 90°, Aspirating and Non-Aspirating, Bovie 2.4mm Disposable Bipolar Ablator 55°, Non-Aspirating, Bovie 1.8mm Disposable Bipolar Ablator 60°, Non-Aspirating K161134Bovie Bantam/PRO Electrosurgical Generator, Bovie DERM 941 Electrosurgical Generator, Bovie DERM 942 Electrosurgical Generator K152777Bovie Disposable Bipolar Ablator

View all 10 devices →

Related Devices (Code: GEI)

K261959Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch (0703-046-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Push Button Switch, Bulk Non-Sterile (0703-046-102);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Rocker Switch (0703-047-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Rocker Switch, Bulk Non-Sterile (0703-047-102)Stryker Instruments K254196HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)Ethicon Endo-Surgery, LLC K261070LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider, Nano-coatedCovidien, LLC K254185Potenza PrimeJeisys Medical Incorporated K262364Ellian Enigma RF DeviceEllian Corp K253859Scarlet Pro (Scarlet Pro)VIOL Co., Ltd.

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.