# K042604: Vally Forge Scientific Malis Bipolar Disposable Finger Operated Electrosurgical Instruments

- Pathway: 510(k) (Special)
- Applicant: Valley Forge Scientific Corp.
- Decided: Oct 22, 2004 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
Longest line of descent: 1 generation back to K850297 (1985). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K910510: Valley Forge Bipolar Pen or Forceps, Valley Forge Scientific Corp. (1991) Summary page 1.
- K896626: Hand Controlled Electrosurgical Pencils, Conmedcorp (1990) Summary page 1.
- K955764: Valley Forge Biploar Loop, Valley Forge Scientific Corp. (1996) Summary page 1.
- K982742: Disposable Hand Switching Pencil, Rocker Switch, One Piece and One Piece Holster Models SB 313 RS, SB 313 RSH, New Deantronics Taiwan, Ltd. (1998) Summary page 1.
- K973554: Valley Forge Bipolar Ball Tip Electrode, Valley Forge Scientific Corp. (1997) Summary page 1.
- K982884: Disposable Hand Switching Pencil, Rocker Switch Two Piece, SB 312RS, Two Disposable Hand Switching Pencil, Rocker Switch, New Deantronics, Ltd. (1998) Summary page 1.
- K932345: Tech-Switch Electrosurgical Pencil, Single Use, Conmedcorp (1994) Summary page 1.
- K850297: Electrosurgical Pencil Holder 720, Birtcher Corp. (1985) Summary page 1.

## Indications for use
Electro-Surgical accessories: Hand-Switching Pen for the removal of tissue and control of bleeding in surgical procedures using high frequency (RF) current.

Source page: https://510kreport.com/device/K042604
Methodology: https://510kreport.com/methodology