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510(k) Data Aggregation
K Number
K992485Device Name
MONOPOLAR ELECTRODES AND CABLES
Manufacturer
Date Cleared
1999-08-27
(32 days)
Product Code
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
US ENDO, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Monopolar Electrodes and Accessories are indicated when Endoscopy is indicated, used primarily to coagulate tissue, for use with HF Electrosurgical Units
Targeted Anatomical sites include primarily, the Abdominal (suprapubic) region.
The device is reusable, non-sterile, for use as follows:
1. Spatula tip-Dissection-Coagulation & manipulation of tissue.
2. L-Hook tip-Dissection & manipulation
3. J-Hook tip-Core out with a knife-cutting effect (ablation)
4. Knife-tip-Coagulate with scalpel-like cutting
5. Button/Needle-tip-Spot coagulation
Device Description
Monopolar Electrodes and Accessories
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