# K991669: PMS 750 Fingerswitch

- Pathway: 510(k) (Traditional)
- Applicant: Wallach Surgical Devices, Inc.
- Decided: Aug 12, 1999 after 90 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: 2 generations back to K914400 (1991). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983761: Aaron Electrosurgical Handcontrol Pencil, Model ESP5, Aaron Medical Industries (1998) Summary page 1.
- K970039: Encore Electrosurgical Handcontrol Pencil (35001-001), Medtrex, Inc. (1997) Summary page 1.
- K936075: Reusable, Hand Controlled Esp, E & M Engineering, Inc. (1994) Summary page 1.
- K932518: Tech-Switch Electrosurgical Pencil, Reusable, Conmedcorp (1993) Summary page 1.

## Indications for use
The PMS750 Reusable (Autoclavable) Fingerswitch Pencil is intended to be used in general electrosurgical applications for cutting and coagulating during electrosurgical procedures. It is provided non-sterile and is intended to be autoclavable for 100+ cycles.

Source page: https://510kreport.com/device/K991669
Methodology: https://510kreport.com/methodology