# K936304: Electrosurgical Pencil

- Pathway: 510(k) (Traditional)
- Applicant: E & M Engineering, Inc.
- Decided: Jun 13, 1994 after 175 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
56 later devices descend from it; 3 cite it directly.
0 of 57 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K103375: Plumepen Integrated Smoke Evacuation Pencil (2011), 20 descendants of its own
- K041868: Valupen,Profile (2004), 19 descendants of its own
- K100597: Harmonic Focus Shears (2010), 18 descendants of its own
- K062712: Erbe Monopolar Attachment for Helix Hydro-Jet, Model P/N 20139-094 (2007), 14 descendants of its own
- K083608: Erbe Hybrid Knife (2009), 13 descendants of its own

## Recalls of this device
- May 11, 2018 · Class II · Z-1941-2018: Products may encroach into the sterile pouch seal thereby increasing the risk of the seal being compromised.
- Jun 5, 2012 · Class II · Z-1990-2012: The carton label for this device has the manufacturer symbol where the expiration date symbol should be. Firm officials met with FDA on 5/17/2012. At which time, they reported various labeling errors 
- Jun 5, 2012 · Class II · Z-1991-2012: The Tyvek pouch label for this device states: 'with holster'; however, this product does not come with a holster. Firm officials met with FDA on 5/17/2012. At which time, they reported various labelin

Source page: https://510kreport.com/device/K936304
Methodology: https://510kreport.com/methodology