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Genicon

Last updated May 23, 2026

Information

Country: US
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Catalogue (258)

Page 4 of 6

Device	Model / Reference	Registries	Class	Status
GeniShield	100-005-090	FDA UDI	Class I	Active
GeniSurge	533-005-935T	FDA UDI	Class II	Active
GeniSurge	533-005-940	FDA UDI	Class II	Active
GeniSurge	FX-533-005-945	FDA UDI	Class II	Active
GeniClip Open Applier	330-005-002	FDA UDI	Class I	Active
GeniPalm	100-108-151	FDA UDI	Class I	Active
GeniStrong	550-000-012G	FDA UDI	Class II	Active
X-Surge	590-005-001	FDA UDI	Class II	Active
GeniStrong	550-000-003G	FDA UDI	Class II	Active
GeniStrong	550-000-010G	FDA UDI	Class II	Active
GeniShield	100-105-091	FDA UDI	Class I	Active
X-Surge	590-005-013	FDA UDI	Class II	Active
2EZee Specimen Retrieval	550-000-200	FDA UDI	Class II	Active
GeniShield	100-005-092	FDA UDI	Class I	Active
X-Surge	590-005-014	FDA UDI	Class II	Active
GeniStrong	550-000-005	FDA UDI	Class II	Active
GeniClip	350-000-102	FDA UDI	Class II	Active
GeniClip Open Applier	330-005-000	FDA UDI	Class I	Active
GeniFlow	700-010-005	FDA UDI	Class II	Active
GeniShield	100-005-192	FDA UDI	Class I	Active
GeniSurge	FX-533-005-950	FDA UDI	Class II	Active
GeniStrong	550-000-013G	FDA UDI	Class II	Active
NanoSurge	528-063-920	FDA UDI	Class I	Active
GeniLook	200-105-151	FDA UDI	Class I	Active
GeniSurge	533-005-945T	FDA UDI	Class II	Active
Probe	700-010-033	FDA UDI	Class II	Active
GeniSurge	FX-533-105-910	FDA UDI	Class II	Active
GeniPalm	100-012-150	FDA UDI	Class I	Active
GeniStrong	550-000-008	FDA UDI	Class II	Active
BiSurge	633-005-920	FDA UDI	Class II	Active
Probe	700-005-045	FDA UDI	Class II	Active
Natura	210-012-250	FDA UDI	Class I	Active
GeniSurge	533-005-940T	FDA UDI	Class II	Active
GeniSurge	533-005-920T	FDA UDI	Class II	Active
SimplyStrong	550-000-013	FDA UDI	Class II	Active
GeniShield	100-005-091	FDA UDI	Class I	Active
GeniLook	200-115-151	FDA UDI	Class I	Active
GeniLook	200-015-151	FDA UDI	Class I	Active
GeniPort	100-105-002	FDA UDI	Class I	Active
GeniLook	200-108-152	FDA UDI	Class I	Active
GeniShield	100-005-190	FDA UDI	Class I	Active
GeniLook	200-005-150	FDA UDI	Class I	Active
GeniSurge	533-105-910T	FDA UDI	Class II	Active
GeniFlow	700-000-005	FDA UDI	Class II	Active
GeniShield	100-005-191	FDA UDI	Class I	Active
Natura	210-010-151	FDA UDI	Class I	Active
GeniLook	200-112-151	FDA UDI	Class I	Active
Natura	210-010-152	FDA UDI	Class I	Active
SimplyStrong	550-000-012	FDA UDI	Class II	Active
GeniLook	200-005-151	FDA UDI	Class I	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.