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EMF PAL II Main Generator and Irrigation Units and Accessories

FDA 510(k)

Class II (US FDA 510(k))

510(k) K062171

by Ortho Development Corp.

Identifiers

510(k) Number
K062171 FDA 510(k)
FDA Product Code
GEI 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 EMF PAL II Main Generator and Irrigation Units and Accessories is an electrosurgical system comprising a main generator unit, irrigation unit, and accessories such as forceps and extension cables. It uses electrical energy to perform coagulation, cutting, and ablation of soft tissues.

This device is operated by surgeons in clinical settings, including operating rooms, for orthopedic, arthroscopic, spinal, and neurosurgical procedures. It is supplied as a system with its associated accessories and is regulated under FDA 510(k) clearance K062171 with product code GEI.

Frequently asked questions

What is the EMF PAL II Main Generator and Irrigation Units and Accessories used for?

The EMF PAL II Main Generator and Irrigation Units and Accessories is used by surgeons to perform coagulation, cutting, and ablation of soft tissues during orthopedic, arthroscopic, spinal, and neurosurgical procedures in clinical settings such as operating rooms.

What components are included in the EMF PAL II system?

The EMF PAL II system includes a main generator unit, an irrigation unit, and accessories such as forceps and extension cables, which together enable electrosurgical functions for tissue coagulation, cutting, and ablation.

How is the EMF PAL II system supplied and regulated?

The EMF PAL II system is supplied as a complete system with its associated accessories and is regulated under FDA 510(k) clearance K062171 with product code GEI, indicating it was found substantially equivalent to a legally marketed predicate device.

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. Sources consulted: Emf Pal Ii Main Generator and Irrigation Units and Accessories, PDF K062171 - Emf Pal Ii Main Generator and Irrigation Units and Accessories, EMF PAL II MAIN GENERATOR AND IRRIGATION UNITS AND ACCESSORIES 510(k ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Ortho Development Corp.

Sources (1)

  • FDA 510(k) K062171 24 fields · synced Sep 22, 2026