# K962044: Valleylab Coated Electrodes

- Pathway: 510(k) (Traditional)
- Applicant: Valleylab, Inc.
- Decided: Aug 30, 1996 after 94 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.
73 later devices descend from it; 8 cite it directly.
0 of 74 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 no predicate by number.

## Most influential descendants
- K073057: Pulsar Generator, Model PS100-100, and Peak Plasmablade Tissue Dissection Device, Model PS200-040 (2008), 33 descendants of its own
- K990362: Instrument, Ultrasonic, Scalpel (1999), 33 descendants of its own
- K073616: Fas-Clean Electrosurgical Coated Active Blade (2008), 25 descendants of its own
- K082786: Pulsar Generator, Peak Plasmablade; 4.0, Needle, and Ext Tissue Dissection Devices (2008), 24 descendants of its own
- K100597: Harmonic Focus Shears (2010), 18 descendants of its own

## Indications for use
Valleylab Coated Electrodes are intended as an alternative to uncoated stainless steel electrodes or “non-stick” coated electrodes for use in conventional monopolar electrosurgical accessories. The Coated Electrodes are intended for use in situations where monopolar electrosurgical cutting and coagulation are normally used.

Source page: https://510kreport.com/device/K962044
Methodology: https://510kreport.com/methodology