# K993647: Unimed Disposable Hand and Foot-Switching Pencils with Holster and 1BLADE and Tip Cleaner, Unimed Disposable Hand and F

- Pathway: 510(k) (Special)
- Applicant: Unimed Surgical Products, Inc.
- Decided: Nov 16, 1999 after 18 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K092634: Obs Disposable Electrosurgical Pencils, Models: Obs-DB, Obs-DR, Obs-DF (2009), 1 descendant of its own
- K170369: Disposable Electrosurgical Pencils (2018), 0 descendants of its own

## Indications for use
The Electrosurgical Pencils and Electrodes are used for the cutting and coagulation of soft tissue. The Intended Use of the modified device, as described in its labeling, has not changed as a result of the modifications and do not alter the scientific technology of the device.

Source page: https://510kreport.com/device/K993647
Methodology: https://510kreport.com/methodology