510(k) · Cleared

Cleared

Porex Electrosurgery Needle

K052297510(k) TraditionalCleared Mar 28, 2006217-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

Porex Surgical, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Mar 28, 2006 as substantially equivalent to K000348 (Stryker Leibinger, 2000) and 2 other predicates after a 217-day review. Its family tree reaches back 1 generation to 1990.

Decided: Mar 28, 2006
Review: 217 days
Class: Class II
Product code: GEI
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K903302 (1990). 3 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK903302 Electrode, ElectrosurgeryMegadyne Medical Products, Inc. · 1990
This deviceK052297 Porex Electrosurgery NeedlePorex Surgical, Inc. · 2006

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K903302	Electrode, Electrosurgery	Megadyne Medical Products, Inc.	1990	—
0 (this device)	K052297	Porex Electrosurgery Needle	Porex Surgical, Inc.	2006	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0
2000	1	0

FIG. 1 — Lineage of K052297, 1990–2006Source: 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? (3)

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
*	K000348	Colorado Microdissection Needle Summary page 1 …eedles are substantially equivalent to the following predicate devices in their intended use, material, design, and surgical procedure; Colorado MicroDissection Needle (K000348) Megadyne Electrode, Electrosurgery (K903302) Valleylab Coated Electrodes (K962044)…	Stryker Leibinger	2000	—
*	K903302	Electrode, Electrosurgery Summary page 1 …lowing predicate devices in their intended use, material, design, and surgical procedure; Colorado MicroDissection Needle (K000348) Megadyne Electrode, Electrosurgery (K903302) Valleylab Coated Electrodes (K962044)…	Megadyne Medical Products, Inc.	1990	—
*	K962044	Valleylab Coated Electrodes Summary page 1 …ded use, material, design, and surgical procedure; Colorado MicroDissection Needle (K000348) Megadyne Electrode, Electrosurgery (K903302) Valleylab Coated Electrodes (K962044) E-I DESCRIPTION The Porex Surg…	Valleylab, Inc.	1996	—

Also cleared against K000348: 4 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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?

None of the 3 ancestors has a recall.
4 other devices also cite its predicate K000348.

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 Porex Electrosurgery Needle is an electrosurgery electrode for use in monopolar electrosurgical handpieces. It is a single-use device intended for cutting, dissecting, and cauterizing of soft tissue.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K052297 · printed Nov 4, 2026

Cite this page

510(k) Report. “K052297: Porex Electrosurgery Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K052297

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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