# K881763: Colorado Needle Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Colorado Biomedical, Inc.
- Decided: Jun 20, 1988 after 56 days
- Product code: JOS (Electrode, Electrosurgical)
- 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.
36 later devices descend from it; 3 cite it directly.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K990362: Instrument, Ultrasonic, Scalpel (1999), 33 descendants of its own
- K100597: Harmonic Focus Shears (2010), 18 descendants of its own
- K031710: Olympus Ultrasonic Surgical System (2003), 18 descendants of its own
- K050885: Olympus Ultrasonic Surgical System Sonosurg (2005), 15 descendants of its own
- K111202: Surgical Tissue Management System (2012), 11 descendants of its own

Source page: https://510kreport.com/device/K881763
Methodology: https://510kreport.com/methodology