# K082584: Given Electrosurgical Needle

- Pathway: 510(k) (Traditional)
- Applicant: Tripps Court Enterprises, Inc.
- Decided: Oct 28, 2009 after 415 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: 2 generations back to K000348 (2000). 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)
- K033232: Colorado Microdissection Needle, Stryker Corp. (2004) Summary page 1.
- K000348: Colorado Microdissection Needle, Stryker Leibinger (2000) Summary page 1.
- K881763: Colorado Needle Electrode, Colorado Biomedical, Inc. (1988) Summary page 1.

## Indications for use
The Given Electrosurgical Needle is used to apply electrosurgical current directly into a spider vein located within the skin. The electrosurgical current destroys the spider vein.

Source page: https://510kreport.com/device/K082584
Methodology: https://510kreport.com/methodology