# K960255: Ceramic Blade Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Utah Medical Products, Inc.
- Decided: Mar 27, 1996 after 70 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 K780977 (1978). 3 ancestors in all.
45 later devices descend from it; 4 cite it directly.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K905263: Utah Essu, Utah Medical Products, Inc. (1991) Summary page 1.
- K913473: E-Z Clean Electrode, Megadyne Medical Products, Inc. (1991) Summary page 1.
- K780977: Single Use Blade Electrode, Aspen Laboratories, Inc. (1978) Summary page 1.

## Most influential descendants
- K073057: Pulsar Generator, Model PS100-100, and Peak Plasmablade Tissue Dissection Device, Model PS200-040 (2008), 33 descendants of its own
- K082786: Pulsar Generator, Peak Plasmablade; 4.0, Needle, and Ext Tissue Dissection Devices (2008), 24 descendants of its own
- K093695: Peak Plasmablade 3.OS Tissue Dissection Device (2010), 8 descendants of its own
- K083415: Peak Plasmablade Tna Tonsil and Adenoid Tissue Dissection Device (2009), 8 descendants of its own
- K081791: E-Z Clean Electrosurgical Electrode (2008), 8 descendants of its own

## Indications for use
The Utah Medical Products, Inc. (UMP) Ceramic Blade Electrodes (CBE) are intended for use in virtually every surgical discipline where flat, paddle-type electrosurgical blades are used for making straight cuts through tissue. The CBE-2XX blades are intended for use in procedures that require precise cuts where only light or no hemostasis is desired. The CBE-1XX blades are intended for use in procedures where a greater level of hemostasis is desired. When an electrosurgical generator blend mode is used for cutting with the CBE-1XX blades, cauterization of the wound will occur while the cut is being made.

Source page: https://510kreport.com/device/K960255
Methodology: https://510kreport.com/methodology