510(k) · Cleared

Recalled · Class II · 2013

Unimed Coated Needle Electrode/Coated Blade Electrode/Coated Ball Electrode

K962935510(k) TraditionalCleared Sep 3, 199636-day reviewClass II21 CFR 878.4400Recalls 13

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Unimed Surgical Products, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Sep 3, 1996 after a 36-day review. The FDA summary names no predicate by number. 30 later devices descend from it. It has been recalled 13 times.

Decided: Sep 3, 1996
Review: 36 days
Class: Class II
Product code: GEI
Recalls: 13
Predicates: 0

30 later devices descend from it, 3 citing it directly.

This deviceK962935 Unimed Coated Needle Electrode/Coated Blade Electrode/Coated Ball…Unimed Surgical Products, Inc. · 1996
Descendant · cites it directly · 25 of its ownK073616 Fas-Clean Electrosurgical Coated Active BladeElectromedics Co., Ltd. · 2008
Descendant · 2 generations on · 24 of its ownK082786 Pulsar Generator, Peak Plasmablade; 4.0, Needle, and Ext Tissue…Peak Surgical, Inc. · 2008 · Recalled
Descendant · 3 generations on · 8 of its ownK093695 Peak Plasmablade 3.OS Tissue Dissection DevicePeak Surgical, Inc. · 2010
Descendant · 3 generations on · 7 of its ownK142410 Elliquence ElectrodesElliquence, LLC · 2015
Descendant · 3 generations on · 6 of its ownK160041 Cobbra RF Tissue DissectorElliquence, LLC · 2016

Showing 5 of 30 descendants. See all descendants

Descendants cleared per year

1997high 4 (2014) · low 0 (1998)2026

Most influential descendants

Showing 5 of 30 · See all

K073616Fas-Clean Electrosurgical Coated Active BladeElectromedics Co., Ltd. · 2008 · cites it directly25descendants
K082786Pulsar Generator, Peak Plasmablade; 4.0, Needle, and Ext Tissue Dissection DevicesPeak Surgical, Inc. · 2008 · 2 generations on24descendants
K093695Peak Plasmablade 3.OS Tissue Dissection DevicePeak Surgical, Inc. · 2010 · 3 generations on8descendants
K142410Elliquence ElectrodesElliquence, LLC · 2015 · 3 generations on7descendants
K160041Cobbra RF Tissue DissectorElliquence, LLC · 2016 · 3 generations on6descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K962935	Unimed Coated Needle Electrode/Coated Blade Electrode/Coated Ball Electrode	Unimed Surgical Products, Inc.	1996	—
+1	K073616	Fas-Clean Electrosurgical Coated Active Blade	Electromedics Co., Ltd.	2008	—
+2	K082786	Pulsar Generator, Peak Plasmablade; 4.0, Needle, and Ext Tissue Dissection…	Peak Surgical, Inc.	2008	1
+3	K093695	Peak Plasmablade 3.OS Tissue Dissection Device	Peak Surgical, Inc.	2010	—
+3	K142410	Elliquence Electrodes	Elliquence, LLC	2015	—
+3	K160041	Cobbra RF Tissue Dissector	Elliquence, LLC	2016	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0
2002	1	0
2008	2	0
2010	3	0
2012	1	0
2013	1	0
2014	4	0
2015	2	0
2016	2	0
2017	1	0
2018	2	0
2019	1	0
2020	3	0
2022	3	0
2024	1	0
2025	1	0
2026	1	0

FIG. 1 — Lineage of K962935, 1996–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in GEI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new GEI device

#1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against?

The FDA summary names no predicate by number.

What descends from it? (30)

See all 30

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K073616	Fas-Clean Electrosurgical Coated Active Blade	Electromedics Co., Ltd.	2008	25
K970066	Unimed Coated Laparoscopic/Arthroscopy/Suction-Irrigation Electrode	Unimed Surgical Products, Inc.	1997	3
K132224	Unimed Surgical Coated Electrosurgical Electrodes	Unimed Surgical Products, Inc.	2013	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Feb 15, 2013	Class II	Z-1347-2013	No Marketing Application	Firm is recalling due to concerns regarding changes that were made to the PTFE coating materials.
Jun 16, 2010	Class II	Z-2292-2012	Process control	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 tissue due to concerns of sterility.
Jun 16, 2010	Class II	Z-2286-2012	Process control	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 tissue due to concerns of sterility.
Jun 16, 2010	Class II	Z-2287-2012	Process control	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 tissue due to concerns of sterility.
Jun 16, 2010	Class II	Z-2296-2012	Process control	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 tissue due to concerns of sterility.
Jun 16, 2010	Class II	Z-2294-2012	Process control	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 tissue due to concerns of sterility.
Jun 16, 2010	Class II	Z-2288-2012	Process control	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 tissue due to concerns of sterility.
Jun 16, 2010	Class II	Z-2295-2012	Process control	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 tissue due to concerns of sterility.
Jun 16, 2010	Class II	Z-2290-2012	Process control	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 tissue due to concerns of sterility.
Jun 16, 2010	Class II	Z-2293-2012	Process control	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 tissue due to concerns of sterility.
Jun 16, 2010	Class II	Z-2289-2012	Process control	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 tissue due to concerns of sterility.
Jun 16, 2010	Class II	Z-2291-2012	Process control	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 tissue due to concerns of sterility.
Aug 28, 2009	Not classified	Z-0069-2010	Process control	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 for Lot #042209-03.

The 5 latest of 13 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K073616 (Electromedics Co., Ltd., 2008) has gone furthest, with 25 descendants of its own.

How does its category compare?

All GEI devices

GEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GEI

52in 2025

2007high 65 (2023) · low 35 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEI

113in 2025

2007high 183 (2026) · low 51 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GEI

4in 2025

2007high 51 (2010) · low 1 (2020)2026

Class I (14 since 2007) Class II/III not classified

Adverse event reports per year · GEI

7,592in 2025

2007high 7,897 (2024) · low 2,556 (2008)2025

MAUDE reports naming product code GEI, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	50	51	21	2,795
2008	61	71	19	2,556
2009	42	130	27	3,591
2010	46	109	51	3,377
2011	35	135	32	4,463
2012	39	133	30	5,216
2013	48	136	13	4,897
2014	49	103	3	4,908
2015	47	123	4	4,936
2016	64	108	3	5,616
2017	52	72	2	6,073
2018	47	93	6	6,545
2019	48	93	5	7,067
2020	59	105	1	6,490
2021	46	146	6	6,354
2022	55	150	49	6,103
2023	65	104	27 (4)	7,176
2024	59	125	22 (10)	7,897
2025	52	113	4	7,592
2026	43	183	8	—

What is it indicated for?

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

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K962935 · printed Nov 4, 2026

Cite this page

510(k) Report. “K962935: Unimed Coated Needle Electrode/Coated Blade Electrode/Coated Ball Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K962935

Report an extraction error

Are you the manufacturer?

Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026