# K041868: Valupen,Profile

- Pathway: 510(k) (Traditional)
- Applicant: Conmed Corporation
- Decided: Sep 28, 2004 after 81 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 K936304 (1994). 1 ancestor in all.
19 later devices descend from it; 1 cites it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K936304: Electrosurgical Pencil, E & M Engineering, Inc. (1994) Summary page 1.

## Most influential descendants
- K100597: Harmonic Focus Shears (2010), 18 descendants of its own
- K133314: Harmonic Focus Shears + Adaptive Tissue Technology (2013), 9 descendants of its own
- K151743: THUNDERBEAT Open Fine Jaw (2016), 6 descendants of its own
- K192103: Thunderbeat Open Fine Jaw Type X Hand Instrument (2020), 4 descendants of its own
- K153371: Sonicision Cordless Ultrasonic Dissection Device (2016), 4 descendants of its own

## Indications for use
Single-use hand-switching electrosurgical accessory handpiece used in conjunction with an electrosurgical generator for delivery of RF electrosurgical current through an electrode for cutting and coagulation at the operative site.

Source page: https://510kreport.com/device/K041868
Methodology: https://510kreport.com/methodology