# K081559: Genesis

- Pathway: 510(k) (Traditional)
- Applicant: Medisiss
- Decided: Aug 28, 2008 after 86 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 K913473 (1991). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962044: Valleylab Coated Electrodes, Valleylab, Inc. (1996) Summary page 1.
- K991855: Conmed Stealth Non-Stick Accessory Electrode, Model 138XXX, Conmedcorp (1999) Summary page 1.
- K913473: E-Z Clean Electrode, Megadyne Medical Products, Inc. (1991) Summary page 1.
- K062350: Surginetics Advantageblade, Surginetics (2007) Summary page 1.
- (no number) Valleylab Uncoated Electrosurgical Blade (E1551X) (Preamendment): named in the summary without a submission number
- (no number) Myco Medical Surgical Blades (non-electrosurgical): named in the summary without a submission number

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

Source page: https://510kreport.com/device/K081559
Methodology: https://510kreport.com/methodology