# K072687: Valleylab Microwave Ablation Generator

- Pathway: 510(k) (Traditional)
- Applicant: Covidien Lp, Formerly Know AS Valleylab, A Divison
- Decided: Nov 25, 2008 after 428 days
- Product code: NEY (System, Ablation, Microwave And 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: 6 generations back to K870028 (1987). 17 ancestors in all.
42 later devices descend from it; 4 cite it directly.
0 of 60 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053290: Cool-Tip RF Generator, Cool-Tip RF System Accessories, Valleylab (2006) Summary page 1.

## Cited in the summary but kept off the family tree
- K011676: Vivawave Microwave System, Vivant Medical, Inc. (2002). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K100744: Certus 140 Microwave Ablation System and Accessories, Model Certus 140 (2010), 39 descendants of its own
- K113237: Certus 140 2.45GHZ Ablation System (2012), 38 descendants of its own
- K133821: Emprint Ablation System (2014), 29 descendants of its own
- K163105: Emprint Ablation System (2016), 13 descendants of its own
- K183153: Microwave Ablation System (2019), 9 descendants of its own

## Indications for use
The Valleylab Microwave Ablation Generator is intended for use in percutaneous, laparoscopic, and intraoperative coagulation (ablation) of soft tissue, including partial or complete ablation of non-resectable liver tumors.

Source page: https://510kreport.com/device/K072687
Methodology: https://510kreport.com/methodology