Aem Disposable Suction Irrigation Handset Model ES1700; Aem Disposable Suction Irrigation Electrodes Model ES077X Series

FDA 510(k)

Class II (US FDA 510(k))

510(k) K122580

Identifiers

510(k) Number: K122580 FDA 510(k)
FDA Product Code: GEI FDA 510(k)
Models / Variants: Aem Disposable Suction Irrigation Handset Model Es1700 FDA 510(k)
Aem Disposable Suction Irrigation Electrodes Model Es077x Series FDA 510(k)

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 878.4400 FDA 510(k)
Regulation Number: 878.4400 FDA 510(k)
Advisory Committee: General, Plastic Surgery FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

The Aem disposable suction irrigation handset model Es1700 and Aem disposable suction irrigation electrodes model Es077x series are medical devices used for suction and irrigation. They are designed to provide a means of suction and irrigation during medical procedures.

The devices are supplied as disposable products and are intended for single-use. They are available in specific models, including Es1700 and Es077x series. The devices have been cleared by the FDA, as indicated by the FDA 510K authorization. The manufacturer, Encision, Inc., provides these devices for use in medical settings.

Frequently asked questions

What is the Aem disposable suction irrigation handset used for?

The Aem disposable suction irrigation handset is used to provide a means of suction and irrigation during medical procedures, and is designed for single-use.

Are the Aem suction irrigation devices supplied sterile?

The description does not explicitly state that the devices are supplied sterile, but they are intended for single-use, implying they should be used in a sterile or controlled environment.

What models are available for the Aem suction irrigation devices?

The available models include the Es1700 handset and the Es077x series electrodes, which are designed to work together for suction and irrigation during medical procedures.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K122580	Class II	Active

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Manufacturer

Manufacturer: Encision, Inc.

Sources (1)

FDA 510(k) K122580 24 fields · synced Sep 23, 2026