510(k) · Cleared

Cleared

Microsurgical Bipolar Handpiece

K024304510(k) TraditionalCleared Feb 25, 200363-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

Neomedix Corp. · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Feb 25, 2003 as substantially equivalent to K010487 (Medtronic PS Medical, 2001) and 7 other predicates after a 63-day review. Its family tree reaches back 2 generations to 1979. 2 later devices descend from it.

Decided: Feb 25, 2003
Review: 63 days
Class: Class II
Product code: GEI
Recalls: None
Predicates: 8

Its longest line of descent runs back 2 generations to K792365 (1979). 15 ancestors in all. 2 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 2 generations backK792365 Bipolar ForcepsConcept, Inc. · 1979
1 generation backK993655 Micro-France Electrosurgical Instruments, VariousXomed, Inc. · 1999 · Recalled
This deviceK024304 Microsurgical Bipolar HandpieceNeomedix Corp. · 2003
Descendant · cites it directly · 1 of its ownK040584 NMX-1000Neomedix Corp. · 2004
Descendant · 2 generations on · 0 of its ownK220891 Kahook Dual Blade Glide (KDB Glide)New World Medical, Inc. · 2024

Most influential descendants

Showing 2 of 2 · See all

K040584NMX-1000Neomedix Corp. · 2004 · cites it directly1descendant
K220891Kahook Dual Blade Glide (KDB Glide)New World Medical, Inc. · 2024 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K792365	Bipolar Forceps	Concept, Inc.	1979	—
−1	K993655	Micro-France Electrosurgical Instruments, Various	Xomed, Inc.	1999	2
0 (this device)	K024304	Microsurgical Bipolar Handpiece	Neomedix Corp.	2003	—
+1	K040584	NMX-1000	Neomedix Corp.	2004	—
+2	K220891	Kahook Dual Blade Glide (KDB Glide)	New World Medical, Inc.	2024	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1989	2	0
1990	1	0
1991	1	0
1995	1	0
1996	2	0
1997	1	0
1998	1	0
1999	1	0
2000	1	0
2001	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2024	1	0

FIG. 1 — Lineage of K024304, 1979–2024Source: 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? (8)

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
*	K010487	Bipolar Pencil, Model 3901-002, 3900-002 Summary page 1 …es The NeoMedix MicroSurgical Bipolar Handpiece is similar in indications, design and features to the following currently marketed devices: Bipolar probes by Medtronic (K010487), Kirwan (K962678), Xomed (K993655), Oratec (K991218) and Mentor (K971538), Storz Bipolar Cautery Probe (K952151), Ethicon Bipola…	Medtronic PS Medical	2001	—
*	K962678	Bipolar Pencil Coagulator Summary page 1 …icroSurgical Bipolar Handpiece is similar in indications, design and features to the following currently marketed devices: Bipolar probes by Medtronic (K010487), Kirwan (K962678), Xomed (K993655), Oratec (K991218) and Mentor (K971538), Storz Bipolar Cautery Probe (K952151), Ethicon Bipolar Device (K003587)…	Kirwan Surgical Products, Inc.	1996	—
*	K993655	Micro-France Electrosurgical Instruments, Various Summary page 1 …lar Handpiece is similar in indications, design and features to the following currently marketed devices: Bipolar probes by Medtronic (K010487), Kirwan (K962678), Xomed (K993655), Oratec (K991218) and Mentor (K971538), Storz Bipolar Cautery Probe (K952151), Ethicon Bipolar Device (K003587) and Wolf Multifu…	Xomed, Inc.	1999	2
*	K991218	Oratec Bipolar Ablation Probes Summary page 1 …imilar in indications, design and features to the following currently marketed devices: Bipolar probes by Medtronic (K010487), Kirwan (K962678), Xomed (K993655), Oratec (K991218) and Mentor (K971538), Storz Bipolar Cautery Probe (K952151), Ethicon Bipolar Device (K003587) and Wolf Multifunction Instrument…	Oratec Interventions, Inc.	1999	—
*	K971538	Mentor Gemini Hemostatic Eraser Summary page 1 …, design and features to the following currently marketed devices: Bipolar probes by Medtronic (K010487), Kirwan (K962678), Xomed (K993655), Oratec (K991218) and Mentor (K971538), Storz Bipolar Cautery Probe (K952151), Ethicon Bipolar Device (K003587) and Wolf Multifunction Instrument (K002000). Indicati…	Mentor Ophthalmics, Inc.	1997	—
*	K952151	Storz Ophthalmic Bipolar Cautery Instruments (D8200, D8201, D8203) and Bipolar Cords… Summary page 1 …currently marketed devices: Bipolar probes by Medtronic (K010487), Kirwan (K962678), Xomed (K993655), Oratec (K991218) and Mentor (K971538), Storz Bipolar Cautery Probe (K952151), Ethicon Bipolar Device (K003587) and Wolf Multifunction Instrument (K002000). Indications for Use The NeoMedix Microsurgical…	Storz	1996	—
*	K003587	Clearglide Precision Bipolar Device Summary page 1 …r probes by Medtronic (K010487), Kirwan (K962678), Xomed (K993655), Oratec (K991218) and Mentor (K971538), Storz Bipolar Cautery Probe (K952151), Ethicon Bipolar Device (K003587) and Wolf Multifunction Instrument (K002000). Indications for Use The NeoMedix Microsurgical Bipolar Handpiece is to be used i…	ETHICON, Inc.	2000	10
*	K002000	Multifuction Suction Irrigation System, Existing of Suction Irrigation Handles, Suction… Summary page 1 …2678), Xomed (K993655), Oratec (K991218) and Mentor (K971538), Storz Bipolar Cautery Probe (K952151), Ethicon Bipolar Device (K003587) and Wolf Multifunction Instrument (K002000). Indications for Use The NeoMedix Microsurgical Bipolar Handpiece is to be used in electrosurgical applications where low pow…	Richard Wolf Medical Instruments Corp.	2001	—

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
K040584	NMX-1000	Neomedix Corp.	2004	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 24 years and passes through 3 companies; a new generation was cleared every 20.0 years on median.
2 of the 15 ancestors have a recall of any class.
Of its descendants, K040584 (Neomedix Corp., 2004) 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.

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 NeoMedix MicroSurgical Bipolar Handpiece is to be used in electrosurgical applications where low power radio frequency current is applied through a bipolar probe for the purpose of cutting and coagulation of soft tissues. The Handpiece is intended to be used in general and ophthalmic surgery where low impedance or wet field conditions exist.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K024304 · printed Nov 3, 2026

Cite this page

510(k) Report. “K024304: Microsurgical Bipolar Handpiece.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K024304

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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