510(k) · Cleared

Cleared

Aem Disposable Suction Irrigation Handset Model ES1700; Aem Disposable Suction Irrigation Electrodes Model ES077X Series

K122580510(k) TraditionalCleared Nov 9, 201278-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

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

Cleared on Nov 9, 2012 as substantially equivalent to K973890 (Conmedcorp, 1998) and 1 other predicate after a 78-day review. Its family tree reaches back 1 generation to 1998. 1 later device descends from it.

Decided: Nov 9, 2012
Review: 78 days
Class: Class II
Product code: GEI
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K973890 (1998). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK973890 Universalplus Laparoscopic Abc/Electrosurgical ElectrodeConmedcorp · 1998
This deviceK122580 Aem Disposable Suction Irrigation Handset Model ES1700; Aem…Encision, Inc. · 2012
Descendant · cites it directly · 0 of its ownK131949 Aem Disposable Suction Irrigation ElectrodesEncision, Inc. · 2013

Most influential descendants

Showing 1 of 1 · See all

K131949Aem Disposable Suction Irrigation ElectrodesEncision, Inc. · 2013 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K973890	Universalplus Laparoscopic Abc/Electrosurgical Electrode	Conmedcorp	1998	—
0 (this device)	K122580	Aem Disposable Suction Irrigation Handset Model ES1700; Aem Disposable Suction…	Encision, Inc.	2012	—
+1	K131949	Aem Disposable Suction Irrigation Electrodes	Encision, Inc.	2013	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2009	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2013	1	0

FIG. 1 — Lineage of K122580, 1998–2013Source: 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? (2)

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
*	K973890	Universalplus Laparoscopic Abc/Electrosurgical Electrode Summary page 1 …rrigation Electrodes Manufacturer ConMed Market Clearance 510(k): K973890 Second Trade Name Encision AEM Disposable Electrodes and Pr…	Conmedcorp	1998	—
*	K091074	Aem Disposable Electrodes,Model ESO300 Series Summary page 1 …H-andpieces Manufacturer Encision Inc. Market Clearance 510(k): K09 1074 Device Description Single-Use Hand-Control AEM Suction Irrigation Electrodes (DSIE) ar…	Encision, Inc.	2009	9

Also cleared against K973890: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K131949	Aem Disposable Suction Irrigation Electrodes	Encision, Inc.	2013	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?

1 of the 2 ancestors has a recall of any class.
Of its descendants, K131949 (Encision, Inc., 2013) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K973890.

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. 2012, this device’s year, is highlighted.

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?

Sterile, single-patient-use electrosurgical accessory initended to conduct electrosurgical current for cutting and coagulation of tissue and/or to provide suction and irrigation fuinctions to the surgical site. These accessories have applications in general endoscopy and laparoscopy procedures.

AEM instruments incorporate the use of AEM technology and are intended for use with the AEM monitoring system and electrosurgical generators compatible with the AEM system.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K122580 · printed Nov 6, 2026

Cite this page

510(k) Report. “K122580: Aem Disposable Suction Irrigation Handset Model ES1700; Aem Disposable Suction Irrigation Electrodes Model ES077X Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122580

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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