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K Number
K972161
Device Name
BOVIE MODEL X15
Manufacturer
MAXXIM MEDICAL
Date Cleared
1997-06-18

(9 days)

Product Code
GEI
Regulation Number
878.4400
Type
Traditional
Panel
SU
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The BOVIE Mođel X15 Electrosurgical Generator is Indicated for Use in laparoscopic surgical procedures for the cutting and coagulation of human tissue. The BOVIE Model X15 can be used in conjunction with the appropriate accessories and instruments for applications in General Surgery.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) premarket notification letter from the FDA regarding the BOVIE Model X15 Electrosurgical Generator. It does not contain information about acceptance criteria, device performance, study designs, sample sizes, or ground truth establishment relevant to an AI/ML medical device.

Therefore, I cannot fulfill your request based on the provided text. The document is a regulatory approval letter, not a clinical study report.

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.