510(k) · Cleared

Cleared

Mitek Electrosurgical System for Arthroscopic Use

K963783510(k) TraditionalCleared Nov 25, 199666-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

ETHICON, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Nov 25, 1996 after a 66-day review. The FDA summary names its predicate without a number. 16 later devices descend from it.

Decided: Nov 25, 1996
Review: 66 days
Class: Class II
Product code: GEI
Recalls: None
Predicates: 0

16 later devices descend from it, 6 citing it directly.

This deviceK963783 Mitek Electrosurgical System for Arthroscopic UseETHICON, Inc. · 1996
Descendant · cites it directly · 12 of its ownK992876 Vapr 2.3 MM Side Effect Electrode for Use with Vapr SystemMitek Products · 1999
Descendant · cites it directly · 12 of its ownK992406 Vapr 2.3MM End Effect Electrode for Use with Vapr SystemMitek Products · 1999
Descendant · 2 generations on · 10 of its ownK041135 Vapr 3 Electrosurgical System and Vapr LD and LP Suction ElectrodesDepuy Mitek, A Johnson & Johnson Company · 2004
Descendant · cites it directly · 9 of its ownK082643 3.5 MM Side Effect Electrode with Integrated Handpiece, Model…Depuy Mitek, A Johnson & Johnson Company · 2008 · Recalled
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 16 descendants. See all descendants

Descendants cleared per year

1999high 2 (1999) · low 0 (2000)2026

Most influential descendants

Showing 5 of 16 · See all

K992876Vapr 2.3 MM Side Effect Electrode for Use with Vapr SystemMitek Products · 1999 · cites it directly12descendants
K992406Vapr 2.3MM End Effect Electrode for Use with Vapr SystemMitek Products · 1999 · cites it directly12descendants
K041135Vapr 3 Electrosurgical System and Vapr LD and LP Suction ElectrodesDepuy Mitek, A Johnson & Johnson Company · 2004 · 2 generations on10descendants
K0826433.5 MM Side Effect Electrode with Integrated Handpiece, Model 227301, 3.5 MM Angled Side…Depuy Mitek, A Johnson & Johnson Company · 2008 · cites it directly9descendants
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)	K963783	Mitek Electrosurgical System for Arthroscopic Use	ETHICON, Inc.	1996	—
+1	K992876	Vapr 2.3 MM Side Effect Electrode for Use with Vapr System	Mitek Products	1999	—
+1	K992406	Vapr 2.3MM End Effect Electrode for Use with Vapr System	Mitek Products	1999	—
+2	K041135	Vapr 3 Electrosurgical System and Vapr LD and LP Suction Electrodes	Depuy Mitek, A Johnson & Johnson Company	2004	—
+1	K082643	3.5 MM Side Effect Electrode with Integrated Handpiece, Model 227301, 3.5 MM…	Depuy Mitek, A Johnson & Johnson Company	2008	2
+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
1999	2	0
2001	2	0
2004	1	0
2006	1	0
2008	1	0
2010	1	0
2012	1	0
2014	1	0
2015	1	0
2016	2	0
2018	1	0
2023	1	0
2025	1	0

FIG. 1 — Lineage of K963783, 1996–2025Source: 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? (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
*	—	ArthroCare Arthroscopic Electrosurgical System Named without a submission number			—

What descends from it? (16)

See all 16

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

Number	Device	Applicant	Decided	Descendants
K992876	Vapr 2.3 MM Side Effect Electrode for Use with Vapr System	Mitek Products	1999	12
K992406	Vapr 2.3MM End Effect Electrode for Use with Vapr System	Mitek Products	1999	12
K082643	3.5 MM Side Effect Electrode with Integrated Handpiece, Model 227301, 3.5 MM Angled Side…	Depuy Mitek, A Johnson & Johnson Company	2008	9
K012631	Reprocessed Soft Tissue Ablators	Alliance Medical Corp.	2001	1
K120095	Side Effect with Hand Controls, Hook Electrode with Hand Controls, 2.3 Wedge Electrode…	Depuy Mitek, A Johnson & Johnson Company	2012	0
K052692	Suretek Medical Reprocessed Electrosurgical Electrodes	Suretek Medical	2006	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, K992876 (Mitek Products, 1999) has gone furthest, with 12 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 Mitek Electrosurgical System is intended for soft tissue resection, ablation, and excision and hemostasis in patients requiring arthroscopic surgery of the knee, shoulder, ankle, elbow and wrist.

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/K963783 · printed Nov 4, 2026

Cite this page

510(k) Report. “K963783: Mitek Electrosurgical System for Arthroscopic Use.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K963783

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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