510(k) · Cleared

Cleared

Evershears Bipolar Scissors

K000496510(k) TraditionalCleared Apr 24, 200069-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

Everest Medical Corp. · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Apr 24, 2000 after a 69-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 17 later devices descend from it.

Decided: Apr 24, 2000
Review: 69 days
Class: Class II
Product code: GEI
Recalls: None
Predicates: 0

17 later devices descend from it, 3 citing it directly.

This deviceK000496 Evershears Bipolar ScissorsEverest Medical Corp. · 2000
Descendant · cites it directly · 14 of its ownK024286 Gyrus Open ForcepsGyrus Medical, Inc. · 2003 · Recalled
Descendant · 2 generations on · 7 of its ownK081503 Aed Monopolar Lap AccessoriesNational Advanced Endoscopy Devices, Inc. · 2008
Descendant · 3 generations on · 6 of its ownK103508 Unmiax Laparoscopic InstrumentUnimax Medical Systems, Inc. · 2011
Descendant · 2 generations on · 4 of its ownK061975 Plasmaseal Open Forceps, Models 2103PK and 91701PKAcmi Corporation · 2006
Descendant · 2 generations on · 3 of its ownK081766 PKS Omni InstrumentGyrus-Acmi L.P. · 2008 · Recalled

Showing 5 of 17 descendants. See all descendants

Descendants cleared per year

2001high 3 (2008) · low 0 (2004)2026

Most influential descendants

Showing 5 of 17 · See all

K024286Gyrus Open ForcepsGyrus Medical, Inc. · 2003 · cites it directly14descendants
K081503Aed Monopolar Lap AccessoriesNational Advanced Endoscopy Devices, Inc. · 2008 · 2 generations on7descendants
K103508Unmiax Laparoscopic InstrumentUnimax Medical Systems, Inc. · 2011 · 3 generations on6descendants
K061975Plasmaseal Open Forceps, Models 2103PK and 91701PKAcmi Corporation · 2006 · 2 generations on4descendants
K081766PKS Omni InstrumentGyrus-Acmi L.P. · 2008 · 2 generations on3descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K000496	Evershears Bipolar Scissors	Everest Medical Corp.	2000	—
+1	K024286	Gyrus Open Forceps	Gyrus Medical, Inc.	2003	6
+2	K081503	Aed Monopolar Lap Accessories	National Advanced Endoscopy Devices, Inc.	2008	—
+3	K103508	Unmiax Laparoscopic Instrument	Unimax Medical Systems, Inc.	2011	—
+2	K061975	Plasmaseal Open Forceps, Models 2103PK and 91701PK	Acmi Corporation	2006	—
+2	K081766	PKS Omni Instrument	Gyrus-Acmi L.P.	2008	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0
2002	1	0
2003	1	0
2006	1	0
2008	3	0
2011	1	0
2012	1	0
2014	1	0
2015	1	0
2016	2	0
2017	1	0
2019	1	0
2023	2	0

FIG. 1 — Lineage of K000496, 2000–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (17)

See all 17

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

Number	Device	Applicant	Decided	Descendants
K024286	Gyrus Open Forceps	Gyrus Medical, Inc.	2003	14
K020585	Zip Open Forceps with Electrosurgical Cut	Gyrus Medical, Inc.	2002	0
K012033	Multifunction Endoscopic Instrument	Seedling Enterprises., LLC	2001	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, K024286 (Gyrus Medical, Inc., 2003) has gone furthest, with 14 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	—

https://510kreport.com/device/K000496 · printed Nov 4, 2026

Cite this page

510(k) Report. “K000496: Evershears Bipolar Scissors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K000496

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026