510(k) · Cleared

Cleared

Serfas, Serfas Generator, Serfas Console, Serfas Probe, Serfas Handpiece Cable, Serfas Footswitch

K991960510(k) TraditionalCleared Aug 13, 199964-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

Stryker Endoscopy · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Aug 13, 1999 after a 64-day review. The FDA summary names its predicate without a number. 27 later devices descend from it.

Decided: Aug 13, 1999
Review: 64 days
Class: Class II
Product code: GEI
Recalls: None
Predicates: 0

27 later devices descend from it, 5 citing it directly.

This deviceK991960 Serfas, Serfas Generator, Serfas Console, Serfas Probe, Serfas…Stryker Endoscopy · 1999
Descendant · cites it directly · 17 of its ownK041810 Serfas Energy SystemStryker Endoscopy · 2004 · Recalled
Descendant · cites it directly · 13 of its ownK033135 Stryker Wireless Universal Footswitch SystemStryker Endoscopy · 2004
Descendant · 2 generations on · 12 of its ownK053510 IR Wireless Foot SwitchLinemaster Switch Corp. · 2006 · Recalled
Descendant · 2 generations on · 9 of its ownK083161 Zen Wireless Footswitch (W1000), Zen Wireless Footswitch Adapter…Conmed Linvatec · 2009
Descendant · 2 generations on · 8 of its ownK100638 Vapr Vue Radiofrequency System ,Model 225024, VPR Vue Wireless…Depuy Mitek, A Johnson & Johnson Company · 2010

Showing 5 of 27 descendants. See all descendants

Descendants cleared per year

2003high 3 (2012) · low 0 (2005)2026

Most influential descendants

Showing 5 of 27 · See all

K041810Serfas Energy SystemStryker Endoscopy · 2004 · cites it directly17descendants
K033135Stryker Wireless Universal Footswitch SystemStryker Endoscopy · 2004 · cites it directly13descendants
K053510IR Wireless Foot SwitchLinemaster Switch Corp. · 2006 · 2 generations on12descendants
K083161Zen Wireless Footswitch (W1000), Zen Wireless Footswitch Adapter (W1100)Conmed Linvatec · 2009 · 2 generations on9descendants
K100638Vapr Vue Radiofrequency System ,Model 225024, VPR Vue Wireless Footswitch, Model 227214Depuy Mitek, A Johnson & Johnson Company · 2010 · 2 generations on8descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K991960	Serfas, Serfas Generator, Serfas Console, Serfas Probe, Serfas Handpiece…	Stryker Endoscopy	1999	—
+1	K041810	Serfas Energy System	Stryker Endoscopy	2004	3
+1	K033135	Stryker Wireless Universal Footswitch System	Stryker Endoscopy	2004	—
+2	K053510	IR Wireless Foot Switch	Linemaster Switch Corp.	2006	2
+2	K083161	Zen Wireless Footswitch (W1000), Zen Wireless Footswitch Adapter (W1100)	Conmed Linvatec	2009	—
+2	K100638	Vapr Vue Radiofrequency System ,Model 225024, VPR Vue Wireless Footswitch…	Depuy Mitek, A Johnson & Johnson Company	2010	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2004	2	0
2006	2	0
2007	1	0
2009	1	0
2010	2	0
2012	3	0
2014	1	0
2015	1	0
2016	3	0
2017	2	0
2018	2	0
2019	1	0
2023	2	0
2024	1	0
2025	2	0

FIG. 1 — Lineage of K991960, 1999–2025Source: 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
*	—	Arthrocare System 2000 Named without a submission number			—
*	—	Mitek VAPR System Named without a submission number			—

What descends from it? (27)

See all 27

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

Number	Device	Applicant	Decided	Descendants
K041810	Serfas Energy System	Stryker Endoscopy	2004	17
K033135	Stryker Wireless Universal Footswitch System	Stryker Endoscopy	2004	13
K121855	Resprocessed Serfas Energy Probe	Stryker Sustainability Solutions	2012	0
K101711	Ceruleau Electrosurgical Probe	Nuortho Surgical, Inc.	2010	0
K031564	CSS	Medical Scientific, Inc.	2003	0

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?

Of its descendants, K041810 (Stryker Endoscopy, 2004) has gone furthest, with 17 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 SERFAS RF system is an electrosurgical system designed for general surgical use, including orthopedic and arthroscopic applications of ablation and coagulation of soft tissues, and hemostasis of blood vessels. The system is intended for use in arthroscopic surgery of the joints such as knee, shoulder, elbow, ankle, hip and wrist. The system is intended for use in saline solution, Ringer's lactate or other conductive solution as an irrigant.

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/K991960 · printed Nov 6, 2026

Cite this page

510(k) Report. “K991960: Serfas, Serfas Generator, Serfas Console, Serfas Probe, Serfas Handpiece Cable, Serfas Footswitch.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991960

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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