# K062171: Emf Pal II Main Generator and Irrigation Units and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Ortho Development Corp.
- Decided: May 25, 2007 after 298 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The device is intended for use in general surgery. The device is intended to be used for general surgical purposes in coagulation, cutting and ablation of soft tissues, including but not limited to orthopedic, arthroscopic, spinal, and neurosurgical procedures. Arthroscopic procedures may include those on the shoulder, elbow, wrist, hip, knee, and ankle. The irrigation unit; forceps and single-use extension cable are accessories to the EMF PAL II designed to be used in soft tissue surgical procedures. Refer to the Instructions for Use Manuals for further information on intended surgical applications and precautions and warnings for use of the device.

Source page: https://510kreport.com/device/K062171
Methodology: https://510kreport.com/methodology