# K982743: Disposable Hand Switching Pencil, Push Button with and Without Holster, Model #'S SB 313 PB, SB 313 PBH

- Pathway: 510(k) (Traditional)
- Applicant: New Deantronics Taiwan, Ltd.
- Decided: Sep 14, 1998 after 39 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

## 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/K982743
Methodology: https://510kreport.com/methodology