# K982884: Disposable Hand Switching Pencil, Rocker Switch Two Piece, SB 312RS, Two Disposable Hand Switching Pencil, Rocker Switch

- Pathway: 510(k) (Traditional)
- Applicant: New Deantronics, Ltd.
- Decided: Sep 14, 1998 after 28 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K042604: Vally Forge Scientific Malis Bipolar Disposable Finger Operated Electrosurgical Instruments (2004), 0 descendants of its own

## Indications for use
Electrosurgical accessory. Hand switching, disposable pencil intended to remove tissue and control bleeding by use of high-frequency electrical current.

Source page: https://510kreport.com/device/K982884
Methodology: https://510kreport.com/methodology