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K Number
K023733
Device Name
COA-COMP/M, AUTOMATED BIPOLAR COAGULATOR
Manufacturer
INGENJORSFIRMAN BJORN BERGDAHL AB
Date Cleared
2003-05-14

(189 days)

Product Code
GEI
Regulation Number
878.4400
Type
Abbreviated
Panel
SU
Reference & Predicate Devices
K870149,K870177
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Coagulation of soft tissue during surgery.

Device Description

Coa-Comp/M Automatic Bipolar Coagulator. Class II device. For coagulation of soft tissue during surgery using Radio Frequency, a pure sine-wave with frequency 512 kHz. Maximum power output 40W into 100 Ohms.

AI/ML Overview

The provided text is a 510(k) summary for the Coa-Comp/M Automatic Bipolar Coagulator. It focuses on establishing substantial equivalence to predicate devices and does NOT contain information regarding acceptance criteria, device performance studies, or details about training/test sets as would be required for an AI/ML device.

Therefore, I cannot provide the requested information. The document is primarily an administrative declaration of substantial equivalence for a non-AI medical 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.