# K943055: Electrosurgical Cutting and Coagulating Device and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Megadyne Medical Products, Inc.
- Decided: Dec 21, 1994 after 177 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
38 later devices descend from it; 2 cite it directly.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K073616: Fas-Clean Electrosurgical Coated Active Blade (2008), 25 descendants of its own
- K082786: Pulsar Generator, Peak Plasmablade; 4.0, Needle, and Ext Tissue Dissection Devices (2008), 24 descendants of its own
- K040699: Laparoscopic Electrode, Reusable Indicator Shaft (Leris) (2004), 11 descendants of its own
- K093695: Peak Plasmablade 3.OS Tissue Dissection Device (2010), 8 descendants of its own
- K052759: Dan Monopolar Lap Accessories (2006), 8 descendants of its own

## Recalls of this device
- Dec 20, 2002 · Not classified · Z-0468-03: The metal substrate cautery tip may break during use.
- Dec 20, 2002 · Not classified · Z-0469-03: The metal substrate cautery tip may break during use.

Source page: https://510kreport.com/device/K943055
Methodology: https://510kreport.com/methodology