510(k) · Cleared

Cleared

Electrosurgical Electrode

K970987510(k) TraditionalCleared May 5, 199748-day reviewClass II21 CFR 878.4400

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

Fusion Medical Technologies, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on May 5, 1997 as substantially equivalent to K923332 (Premier Dental Products Co., 1992) after a 48-day review. Its family tree reaches back 1 generation to 1992. 118 later devices descend from it.

Decided: May 5, 1997
Review: 48 days
Class: Class II
Product code: GEI
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K923332 (1992). 118 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK923332 Electrosurgical ElectrodesPremier Dental Products Co. · 1992
This deviceK970987 Electrosurgical ElectrodeFusion Medical Technologies, Inc. · 1997
Descendant · cites it directly · 117 of its ownK992931 Non-Stick Bipolar ForcepsSilverglide Surgical Technologies · 1999
Descendant · 2 generations on · 92 of its ownK011722 Atricure Bipolar Coagulation SystemAtriCure, Inc. · 2001
Descendant · 3 generations on · 90 of its ownK020919 Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1AtriCure, Inc. · 2002
Descendant · 4 generations on · 42 of its ownK040690 Surgifrost 10 CM Cryosurgical Device Plus Frostbyte Clamp and…Cryocath Technologies, Inc. · 2004
Descendant · 4 generations on · 34 of its ownK031247 Cardioblate Bipolar Radiofrequency Surgical Ablation SystemMedtronic Vascular · 2003

Showing 5 of 118 descendants. See all descendants

Descendants cleared per year

1999high 11 (2006) · low 0 (2000)2026

Most influential descendants

Showing 5 of 118 · See all

K992931Non-Stick Bipolar ForcepsSilverglide Surgical Technologies · 1999 · cites it directly117descendants
K011722Atricure Bipolar Coagulation SystemAtriCure, Inc. · 2001 · 2 generations on92descendants
K020919Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1AtriCure, Inc. · 2002 · 3 generations on90descendants
K040690Surgifrost 10 CM Cryosurgical Device Plus Frostbyte Clamp and Cryosurgical ConsoleCryocath Technologies, Inc. · 2004 · 4 generations on42descendants
K031247Cardioblate Bipolar Radiofrequency Surgical Ablation SystemMedtronic Vascular · 2003 · 4 generations on34descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K923332	Electrosurgical Electrodes	Premier Dental Products Co.	1992	—
0 (this device)	K970987	Electrosurgical Electrode	Fusion Medical Technologies, Inc.	1997	—
+1	K992931	Non-Stick Bipolar Forceps	Silverglide Surgical Technologies	1999	—
+2	K011722	Atricure Bipolar Coagulation System	AtriCure, Inc.	2001	—
+3	K020919	Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1	AtriCure, Inc.	2002	—
+4	K040690	Surgifrost 10 CM Cryosurgical Device Plus Frostbyte Clamp and Cryosurgical…	Cryocath Technologies, Inc.	2004	—
+4	K031247	Cardioblate Bipolar Radiofrequency Surgical Ablation System	Medtronic Vascular	2003	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0
2001	1	0
2002	1	0
2003	1	0
2004	3	0
2005	4	0
2006	11	0
2007	5	0
2008	11	0
2009	5	0
2010	4	0
2011	6	0
2012	8	0
2013	5	0
2014	6	0
2015	3	0
2016	4	0
2017	2	0
2018	5	0
2019	8	0
2020	3	0
2021	2	0
2022	5	0
2023	2	0
2024	6	0
2025	2	0
2026	4	0

FIG. 1 — Lineage of K970987, 1992–2026Source: 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? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K923332	Electrosurgical Electrodes Summary page 2 …e Technological Characteristics of the Device Compare to Those of the Predicate or Legally Marketed Device. Parameter Fusion Ball Tip Electrode Premier Dental Electrode K923332 Indications for Use Intended for use by Intended for use by practitioners in a manner identical to similar electrosurgical elect…	Premier Dental Products Co.	1992	—

What descends from it? (118)

See all 118

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K992931	Non-Stick Bipolar Forceps	Silverglide Surgical Technologies	1999	117

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

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K992931 (Silverglide Surgical Technologies, 1999) has gone furthest, with 117 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?

Intended for use by practitioners in a manner identical to similar electrosurgical electrodes of this type presently in commercial distribution. It is intended to provide electrocautery over a large surface.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K970987 · printed Nov 4, 2026

Cite this page

510(k) Report. “K970987: Electrosurgical Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970987

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