# K160103: Spetzler Malis Dual Illuminating Bipolar Forceps

- Pathway: 510(k) (Traditional)
- Applicant: Synergetics
- Decided: Oct 12, 2016 after 267 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: 4 generations back to K884656 (1988). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121426: Aynergetics Disposable Spetzler-Malis Standard Bipolar Forceps, Synergetics, Inc. (2012) Summary page 4.

## Most influential descendants
- K213610: Kogent Disposable Copper Forceps, Kogent Disposable Irrigating Copper Forceps, Kogent Disposable Illuminating Copper Forceps (2022), 0 descendants of its own

## Indications for use
The Spetzler™-Malis® Dual Illuminating Bipolar Forceps are designed for use with the Malis® Bipolar electrosurgical generators. The disposable Spetzler™-Malis® Dual Illuminating Bipolar Forceps are single use devices sold sterile and are intended for use in electrosurgery for coagulation of tissue and to supply light for surgical procedures.

Source page: https://510kreport.com/device/K160103
Methodology: https://510kreport.com/methodology