AESCULAP'S MODULAR ENDOSCOPIC INSTRUMENTS FOR GYNECOLOGY

• K Number: K010752
• Device Name: AESCULAP'S MODULAR ENDOSCOPIC INSTRUMENTS FOR GYNECOLOGY
• Manufacturer: AESCULAP, INC.
• Date Cleared: 2001-06-11 ( 90 days)
• Product Code: KNF
• Regulation Number: 884.4160

Intended Use

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Device Description

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Predicate Devices

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Reference Devices

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AI/ML (Artificial Intelligence / Machine Learning)

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Therapeutic

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Diagnostic

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SaMD (Software as a Medical Device)

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IVD (In Vitro Diagnostic)

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PCCP (Predetermined Change Control Plan) Authorized

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Overview

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Regulation Number and Section

§ 884.4160 Unipolar endoscopic coagulator-cutter and accessories.

(a)
Identification. A unipolar endoscopic coagulator-cutter is a device designed to destroy tissue with high temperatures by directing a high frequency electrical current through the tissue between an energized probe and a grounding plate. It is used in female sterilization and in other operative procedures under endoscopic observation. This generic type of device may include the following accessories: an electrical generator, probes and electrical cables, and a patient grounding plate. This generic type of device does not include devices used to perform female sterilization under hysteroscopic observation.(b)
Classification. Class II (performance standards).

Summary

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