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K Number
K033003
Device Name
SUCTION COAGULATOR
Manufacturer
MODERN MEDICAL EQUIPMENT MFG., LTD.
Date Cleared
2004-05-13

(231 days)

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

Suction coagulator is used for coagulating tissue and removing fluid and debris from Suction coagulation is assulation can be performed independently or simultaneously.

Device Description

Suction Coagulator

AI/ML Overview

This letter is a 510(k) clearance for a Suction Coagulator, indicating substantial equivalence to a predicate device. It does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria. The document only specifies the indications for use for the device.

§ 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.