510(k) · Cleared

Recalled · Class II · 2018

Genicon Trocar

K982472510(k) TraditionalCleared Feb 4, 1999204-day reviewClass I21 CFR 878.4800Recalls 15

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Genicon, LC · GEA Cannula, Surgical, General & Plastic Surgery

Cleared on Feb 4, 1999 after a 204-day review. The FDA summary names its predicate without a number. It has been recalled 15 times.

Decided: Feb 4, 1999
Review: 204 days
Class: Class I
Product code: GEA
Recalls: 15
Predicates: 0

The FDA summary names its predicate without a number.

FIG. 1 — Lineage of K982472Source: FDA 510(k) database · 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 GEA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin 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
*	—	Apple Medical Hunt/Reich Trocar Named without a submission number			—
*	—	Core Dynamics Entrée II Named without a submission number			—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Aug 21, 2018	Class II	Z-2275-2020	Process control	There is potential for the plastic optical tip to become detached from the metal shaft.
Aug 21, 2018	Class II	Z-2276-2020	Process control	There is potential for the plastic optical tip to become detached from the metal shaft.
Aug 21, 2018	Class II	Z-2274-2020	Process control	There is potential for the plastic optical tip to become detached from the metal shaft.
Aug 21, 2018	Class II	Z-2267-2020	Process control	There is potential for the plastic optical tip to become detached from the metal shaft.
Aug 21, 2018	Class II	Z-2278-2020	Process control	There is potential for the plastic optical tip to become detached from the metal shaft.
Aug 21, 2018	Class II	Z-2277-2020	Process control	There is potential for the plastic optical tip to become detached from the metal shaft.
Aug 21, 2018	Class II	Z-2271-2020	Process control	There is potential for the plastic optical tip to become detached from the metal shaft.
Aug 21, 2018	Class II	Z-2272-2020	Process control	There is potential for the plastic optical tip to become detached from the metal shaft.
Aug 21, 2018	Class II	Z-2269-2020	Process control	There is potential for the plastic optical tip to become detached from the metal shaft.
Aug 21, 2018	Class II	Z-2270-2020	Process control	There is potential for the plastic optical tip to become detached from the metal shaft.
Aug 21, 2018	Class II	Z-2268-2020	Process control	There is potential for the plastic optical tip to become detached from the metal shaft.
Aug 21, 2018	Class II	Z-2273-2020	Process control	There is potential for the plastic optical tip to become detached from the metal shaft.
Aug 21, 2018	Class II	Z-2266-2020	Process control	There is potential for the plastic optical tip to become detached from the metal shaft.
Aug 21, 2018	Class II	Z-2279-2020	Process control	There is potential for the plastic optical tip to become detached from the metal shaft.
Sep 25, 2008	Not classified	Z-0622-2009	Manufacturing material removal	The stainless steel tips on the Genicon 5mm Pyramidal Trocar exhibited contamination that resembled rust and there was also pitting on the tip of the trocar.

The 5 latest of 15 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

How does its category compare?

All GEA devices

GEA Cannula, Surgical, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GEA

FDA has decided no GEA device since 2007.

Median 510(k) review, days · GEA

Too few GEA 510(k)s in any year since 2007 to give a median.

Recalls per year · GEA

1in 2024

2007high 1 (2008) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · GEA

71in 2025

2007high 158 (2020) · low 3 (2012)2025

MAUDE reports naming product code GEA, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	0	7
2008	—	1	15
2009	—	0	14
2010	—	0	14
2011	—	0	11
2012	—	0	3
2013	—	0	7
2014	—	0	8
2015	—	0	11
2016	—	0	63
2017	—	0	46
2018	—	0	58
2019	—	0	62
2020	—	0	158
2021	—	0	149
2022	—	0	83
2023	—	0	74
2024	—	1	98
2025	—	0	71
2026	—	0	—

What is it indicated for?

The GeniCon trocar is available in 5, 7/8, 10 and 12mm diameter with either a pyramidal or conical tip. This trocar has application in gynecologic, general, thoracic and urology endoscopic procedures to establish a port of entry for instrumentation.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K982472 · printed Nov 4, 2026

Cite this page

510(k) Report. “K982472: Genicon Trocar.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982472

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Page last updated Nov 3, 2026