510(k) · Cleared

Cleared

Conmed R Sabre Genesis TM Electrosurgical Unit; Coned R Sabre Genesis TM Electrosurgical Unit (230V); Conmed Hyfresurg O

K103665510(k) TraditionalCleared Feb 16, 201162-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

Conmed Corporation · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Feb 16, 2011 as substantially equivalent to K052009 (Conmed Corporation, 2005) and 1 other predicate after a 62-day review. Its family tree reaches back 2 generations to 1991. 2 later devices descend from it.

Decided: Feb 16, 2011
Review: 62 days
Class: Class II
Product code: GEI
Recalls: None
Predicates: 2

Its longest line of descent runs back 2 generations to K905654 (1991). 4 ancestors in all. 2 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 2 generations backK905654 Electrosurgical Unit with AccessoriesAspen Labs · 1991
1 generation backK052009 Conmed System Model 2450 Electrosurgical GeneratorConmed Corporation · 2005 · Recalled
This deviceK103665 Conmed R Sabre Genesis TM Electrosurgical Unit; Coned R Sabre…Conmed Corporation · 2011
Descendant · cites it directly · 1 of its ownK140578 Arthroscopic Energy SystemConmed Corporation · 2014 · Recalled
Descendant · 2 generations on · 0 of its ownK153499 EDGE Arthroscopic Energy System, Arthroscopic Energy System Probes…Conmed Corporation · 2015

Most influential descendants

Showing 2 of 2 · See all

K140578Arthroscopic Energy SystemConmed Corporation · 2014 · cites it directly1descendant
K153499EDGE Arthroscopic Energy System, Arthroscopic Energy System Probes, Arthroscopic Energy…Conmed Corporation · 2015 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K905654	Electrosurgical Unit with Accessories	Aspen Labs	1991	—
−1	K052009	Conmed System Model 2450 Electrosurgical Generator	Conmed Corporation	2005	5
0 (this device)	K103665	Conmed R Sabre Genesis TM Electrosurgical Unit; Coned R Sabre Genesis TM…	Conmed Corporation	2011	—
+1	K140578	Arthroscopic Energy System	Conmed Corporation	2014	1
+2	K153499	EDGE Arthroscopic Energy System, Arthroscopic Energy System Probes…	Conmed Corporation	2015	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1995	1	0
2002	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2014	1	0
2015	1	0

FIG. 1 — Lineage of K103665, 1991–2015Source: 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

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What was it cleared against? (2)

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
*	K052009	Conmed System Model 2450 Electrosurgical Generator Summary page 1 …neral and Plastic Surgery D. Predicate Device Name CONMED® System 2450Tm Electrosurgical Unit ConMed Electrosurgery 5 10O(k) K052009 CONMED® System 5000OTM Electrosurgical Unit ConMed Elecarosurgery 510(k) K020186 Sabre…	Conmed Corporation	2005	5
*	K020186	Conmed System 5000 Esu Summary page 1 …ConMed Electrosurgery 5 10O(k) K052009 CONMED® System 5000OTM Electrosurgical Unit ConMed Elecarosurgery 510(k) K020186 Sabre Genesis Section E l-lyFreSurIg OP…	Conmedcorp	2002	1

What descends from it? (2)

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

Number	Device	Applicant	Decided	Descendants
K140578	Arthroscopic Energy System	Conmed Corporation	2014	1

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?

The line of descent spans 20 years and passes through 2 companies; a new generation was cleared every 14.5 years on median.
2 of the 4 ancestors have a recall of any class.
Of its descendants, K140578 (Conmed Corporation, 2014) has gone furthest, with 1 descendant 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. 2011, this device’s year, is highlighted.

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?

General-purpose electrosurgical generator used in conjunction with an electrosurgical accessory handpiece for delivery of RIF (radio frequency) electrosurgical content through an accessory electrode for the cutting and coagulation at the operative site.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K103665 · printed Nov 5, 2026

Cite this page

510(k) Report. “K103665: Conmed R Sabre Genesis TM Electrosurgical Unit; Coned R Sabre Genesis TM Electrosurgical Unit (230V); Conmed Hyfresurg O.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K103665

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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