510(k) · Cleared

Cleared

Everest Bipolar L Hook & PK Bipolar L Hook

K031082510(k) SpecialCleared May 21, 200347-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

Gyrus Medical, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on May 21, 2003 as substantially equivalent to K904993 (Everest Medical Corp., 1991) after a 47-day review. Its family tree reaches back 1 generation to 1991. 15 later devices descend from it.

Decided: May 21, 2003
Review: 47 days
Class: Class II
Product code: GEI
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K904993 (1991). 15 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK904993 Laparoscopic Electrosurgical DeviceEverest Medical Corp. · 1991
This deviceK031082 Everest Bipolar L Hook & PK Bipolar L HookGyrus Medical, Inc. · 2003
Descendant · cites it directly · 8 of its ownK041633 Gyrus Plasmacision Laparoscopic SpatulaGyrus Medical, Inc. · 2004
Descendant · cites it directly · 6 of its ownK050460 Gyrus Plasmacision and Plasmablend ElectrodesGyrus Medical, Inc. · 2005
Descendant · 2 generations on · 3 of its ownK111059 Gyrus Acmil Bipolarlaproscopic Loop (PKS Bill)Gyrus Acmi, Inc. · 2011
Descendant · 2 generations on · 3 of its ownK081766 PKS Omni InstrumentGyrus-Acmi L.P. · 2008 · Recalled
Descendant · 3 generations on · 2 of its ownK161825 PK AIMGyrus Acmi, Inc. · 2016

Showing 5 of 15 descendants. See all descendants

Descendants cleared per year

2004high 3 (2016) · low 0 (2006)2026

Most influential descendants

Showing 5 of 15 · See all

K041633Gyrus Plasmacision Laparoscopic SpatulaGyrus Medical, Inc. · 2004 · cites it directly8descendants
K050460Gyrus Plasmacision and Plasmablend ElectrodesGyrus Medical, Inc. · 2005 · cites it directly6descendants
K111059Gyrus Acmil Bipolarlaproscopic Loop (PKS Bill)Gyrus Acmi, Inc. · 2011 · 2 generations on3descendants
K081766PKS Omni InstrumentGyrus-Acmi L.P. · 2008 · 2 generations on3descendants
K161825PK AIMGyrus Acmi, Inc. · 2016 · 3 generations on2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K904993	Laparoscopic Electrosurgical Device	Everest Medical Corp.	1991	—
0 (this device)	K031082	Everest Bipolar L Hook & PK Bipolar L Hook	Gyrus Medical, Inc.	2003	—
+1	K041633	Gyrus Plasmacision Laparoscopic Spatula	Gyrus Medical, Inc.	2004	—
+1	K050460	Gyrus Plasmacision and Plasmablend Electrodes	Gyrus Medical, Inc.	2005	—
+2	K111059	Gyrus Acmil Bipolarlaproscopic Loop (PKS Bill)	Gyrus Acmi, Inc.	2011	—
+2	K081766	PKS Omni Instrument	Gyrus-Acmi L.P.	2008	1
+3	K161825	PK AIM	Gyrus Acmi, Inc.	2016	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2005	1	0
2008	2	0
2011	1	0
2012	1	0
2013	1	0
2014	2	0
2015	1	0
2016	3	0
2017	1	0
2022	1	0

FIG. 1 — Lineage of K031082, 1991–2022Source: 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
*	K904993	Laparoscopic Electrosurgical Device Summary page 1 …Everest Bipolar L Hook and Gyrus Bipolar L Hook The device is a Class I1 medical device. The Bipolar L Hook is a modification to the predicate device cleared under K904993. The Bipolar L Hook is identical in construction (with the exception of shaft length) and in component materials when compared to…	Everest Medical Corp.	1991	—

Also cleared against K904993: 11 other devices →

What descends from it? (15)

See all 15

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

Number	Device	Applicant	Decided	Descendants
K041633	Gyrus Plasmacision Laparoscopic Spatula	Gyrus Medical, Inc.	2004	8
K050460	Gyrus Plasmacision and Plasmablend Electrodes	Gyrus Medical, Inc.	2005	6

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?

Its one ancestor has no recall.
Of its descendants, K041633 (Gyrus Medical, Inc., 2004) has gone furthest, with 8 descendants of its own.
11 other devices also cite its predicate K904993.

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?

Electrosurgical coagulation, electrosurgical cutting, dissection of tissue, irrigation and

aspiration during the performance of laparoscopic and general surgical procedures.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K031082 · printed Nov 6, 2026

Cite this page

510(k) Report. “K031082: Everest Bipolar L Hook & PK Bipolar L Hook.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031082

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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