# K062350: Surginetics Advantageblade

- Pathway: 510(k) (Traditional)
- Applicant: Surginetics
- Decided: Feb 26, 2007 after 199 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Valleylab Uncoated E1551X: named in the summary without a submission number
- (no number) Valleylab Coated E1450X EDGE: named in the summary without a submission number

## Most influential descendants
- K081559: Genesis (2008), 0 descendants of its own

## Indications for use
The Surginetics AdvantageBladeTM coated electrodes are indicated for use in surgical procedures (general, neurosurgical, laparoscopic, orthopedic, gynecologic, etc.) where monopolar electrosurgical cutting and coagulation are normally used. The coated electrodes are an alternative to conventional monopolar electrosurgical electrodes used for these indications.

Source page: https://510kreport.com/device/K062350
Methodology: https://510kreport.com/methodology