# K962935: Unimed Coated Needle Electrode/Coated Blade Electrode/Coated Ball Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Unimed Surgical Products, Inc.
- Decided: Sep 3, 1996 after 36 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 13 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
30 later devices descend from it; 3 cite it directly.
0 of 31 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
- 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
- K093695: Peak Plasmablade 3.OS Tissue Dissection Device (2010), 8 descendants of its own
- K142410: Elliquence Electrodes (2015), 7 descendants of its own
- K160041: Cobbra RF Tissue Dissector (2016), 6 descendants of its own

## Recalls of this device
- Feb 15, 2013 · Class II · Z-1347-2013: Firm is recalling due to concerns regarding changes that were made to the PTFE coating materials.
- Jun 16, 2010 · Class II · Z-2292-2012: On 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a recall of the Medline Industries, Inc. Electrosurgical electrodes used for cutting and coagulation of soft 
- Jun 16, 2010 · Class II · Z-2286-2012: On 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a recall of the Medline Industries, Inc. Electrosurgical electrodes used for cutting and coagulation of soft 
- Jun 16, 2010 · Class II · Z-2287-2012: On 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a recall of the Medline Industries, Inc. Electrosurgical electrodes used for cutting and coagulation of soft 
- Jun 16, 2010 · Class II · Z-2296-2012: On 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a recall of the Medline Industries, Inc. Electrosurgical electrodes used for cutting and coagulation of soft 
- Jun 16, 2010 · Class II · Z-2294-2012: On 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a recall of the Medline Industries, Inc. Electrosurgical electrodes used for cutting and coagulation of soft 
- Jun 16, 2010 · Class II · Z-2288-2012: On 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a recall of the Medline Industries, Inc. Electrosurgical electrodes used for cutting and coagulation of soft 
- Jun 16, 2010 · Class II · Z-2295-2012: On 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a recall of the Medline Industries, Inc. Electrosurgical electrodes used for cutting and coagulation of soft 
- Jun 16, 2010 · Class II · Z-2290-2012: On 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a recall of the Medline Industries, Inc. Electrosurgical electrodes used for cutting and coagulation of soft 
- Jun 16, 2010 · Class II · Z-2293-2012: On 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a recall of the Medline Industries, Inc. Electrosurgical electrodes used for cutting and coagulation of soft 
- Jun 16, 2010 · Class II · Z-2289-2012: On 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a recall of the Medline Industries, Inc. Electrosurgical electrodes used for cutting and coagulation of soft 
- Jun 16, 2010 · Class II · Z-2291-2012: On 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a recall of the Medline Industries, Inc. Electrosurgical electrodes used for cutting and coagulation of soft 
- Aug 28, 2009 · Not classified · Z-0069-2010: Unimed Surgical Products, Inc., Largo, FL initiated a voluntary recall of the Extended PTFE Coated Blade electrosurgical electrodes, product number ES0014, due to concerns regarding product sterility 

## Indications for use
The unimed Coated Electrodes are indicated for use in the cuffing and coagulation of soft tissue.

Source page: https://510kreport.com/device/K962935
Methodology: https://510kreport.com/methodology