# K052297: Porex Electrosurgery Needle

- Pathway: 510(k) (Traditional)
- Applicant: Porex Surgical, Inc.
- Decided: Mar 28, 2006 after 217 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
Longest line of descent: 1 generation back to K903302 (1990). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000348: Colorado Microdissection Needle, Stryker Leibinger (2000) Summary page 1.
- K903302: Electrode, Electrosurgery, Megadyne Medical Products, Inc. (1990) Summary page 1.
- K962044: Valleylab Coated Electrodes, Valleylab, Inc. (1996) Summary page 1.

## Indications for use
The Porex Electrosurgery Needle is an electrosurgery electrode for use in monopolar electrosurgical handpieces. It is a single-use device intended for cutting, dissecting, and cauterizing of soft tissue.

Source page: https://510kreport.com/device/K052297
Methodology: https://510kreport.com/methodology