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Genicon

Last updated May 23, 2026

Information

Country: US
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Catalogue (258)

Page 6 of 6

Device	Model / Reference	Registries	Class	Status
Ezee Retrieval	K180579	FDA 510(k)	Class II	Active
Genistrong	K180836	FDA 510(k)	Class II	Active
Genistrong Single-Use Specimen Retrieval Bag	K132375	FDA 510(k)	Class II	Active
X-Surge	K171752	FDA 510(k)	Class II	Active
Genicon Disposable Electrosurgical Instrumentation, Model 533-005-910	K061417	FDA 510(k)	Class II	Active
Implantable Clip	K100090	FDA 510(k)	Class II	Active
Simplystrong, Simplyezee	K181791	FDA 510(k)	Class II	Active
Genicon Bipolar Forceps Model # 600-005-005	K041968	FDA 510(k)	Class II	Active

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FDA Recalls (18)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Sep 17, 2020	Z-0310-2021	—	open, classified	Device malfunction causing the applier to jam, and clip loading failures.
Aug 25, 2020	Z-0094-2021	—	open, classified	The product design incorporating a motor driven impeller pump powered by one 9V alkaline battery inside the hand-piece did not receive proper premarket clearance from US FDA and lacks a 510(k).
Aug 21, 2018	Z-2267-2020	—	open, classified	There is potential for the plastic optical tip to become detached from the metal shaft.
Aug 21, 2018	Z-2269-2020	—	open, classified	There is potential for the plastic optical tip to become detached from the metal shaft.
Aug 21, 2018	Z-2271-2020	—	open, classified	There is potential for the plastic optical tip to become detached from the metal shaft.
Aug 21, 2018	Z-2270-2020	—	open, classified	There is potential for the plastic optical tip to become detached from the metal shaft.
Aug 21, 2018	Z-2272-2020	—	open, classified	There is potential for the plastic optical tip to become detached from the metal shaft.
Aug 21, 2018	Z-2274-2020	—	open, classified	There is potential for the plastic optical tip to become detached from the metal shaft.
Aug 21, 2018	Z-2268-2020	—	open, classified	There is potential for the plastic optical tip to become detached from the metal shaft.
Aug 21, 2018	Z-2277-2020	—	open, classified	There is potential for the plastic optical tip to become detached from the metal shaft.
Aug 21, 2018	Z-2266-2020	—	open, classified	There is potential for the plastic optical tip to become detached from the metal shaft.
Aug 21, 2018	Z-2276-2020	—	open, classified	There is potential for the plastic optical tip to become detached from the metal shaft.
Aug 21, 2018	Z-2279-2020	—	open, classified	There is potential for the plastic optical tip to become detached from the metal shaft.
Aug 21, 2018	Z-2275-2020	—	open, classified	There is potential for the plastic optical tip to become detached from the metal shaft.
Aug 21, 2018	Z-2273-2020	—	open, classified	There is potential for the plastic optical tip to become detached from the metal shaft.
Aug 21, 2018	Z-2278-2020	—	open, classified	There is potential for the plastic optical tip to become detached from the metal shaft.
Jun 27, 2018	Z-2005-2020	—	open, classified	Genicon is providing updated IFU labeling to users to provide clarity on how to use the device for multiple specimen retrieval.
Jul 19, 2017	Z-1076-2018	—	terminated	Plastic handle is breaking off of shaft inhibiting proper removal per Instructions for Use.