# K982472: Genicon Trocar

- Pathway: 510(k) (Traditional)
- Applicant: Genicon, LC
- Decided: Feb 4, 1999 after 204 days
- Product code: GEA (Cannula, Surgical, General & Plastic Surgery)
- Device class: 1
- Regulation: 21 CFR 878.4800
- Recalls of this device: 15 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Apple Medical Hunt/Reich Trocar: named in the summary without a submission number
- (no number) Core Dynamics Entrée II: named in the summary without a submission number

## Recalls of this device
- Aug 21, 2018 · Class II · Z-2275-2020: There is potential for the plastic optical tip to become detached from the metal shaft.
- Aug 21, 2018 · Class II · Z-2276-2020: There is potential for the plastic optical tip to become detached from the metal shaft.
- Aug 21, 2018 · Class II · Z-2274-2020: There is potential for the plastic optical tip to become detached from the metal shaft.
- Aug 21, 2018 · Class II · Z-2267-2020: There is potential for the plastic optical tip to become detached from the metal shaft.
- Aug 21, 2018 · Class II · Z-2278-2020: There is potential for the plastic optical tip to become detached from the metal shaft.
- Aug 21, 2018 · Class II · Z-2277-2020: There is potential for the plastic optical tip to become detached from the metal shaft.
- Aug 21, 2018 · Class II · Z-2271-2020: There is potential for the plastic optical tip to become detached from the metal shaft.
- Aug 21, 2018 · Class II · Z-2272-2020: There is potential for the plastic optical tip to become detached from the metal shaft.
- Aug 21, 2018 · Class II · Z-2269-2020: There is potential for the plastic optical tip to become detached from the metal shaft.
- Aug 21, 2018 · Class II · Z-2270-2020: There is potential for the plastic optical tip to become detached from the metal shaft.
- Aug 21, 2018 · Class II · Z-2268-2020: There is potential for the plastic optical tip to become detached from the metal shaft.
- Aug 21, 2018 · Class II · Z-2273-2020: There is potential for the plastic optical tip to become detached from the metal shaft.
- Aug 21, 2018 · Class II · Z-2266-2020: There is potential for the plastic optical tip to become detached from the metal shaft.
- Aug 21, 2018 · Class II · Z-2279-2020: There is potential for the plastic optical tip to become detached from the metal shaft.
- Sep 25, 2008 · Not classified · Z-0622-2009: 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.

## Indications for use
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.

Source page: https://510kreport.com/device/K982472
Methodology: https://510kreport.com/methodology