Genicon, Inc.
Medical device manufacturer in Winter Park, FL.
11510(k) clearances
0PMA approvals
18recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K190168 | Aquas ProbesGEI · Special | 03/14/2019SE |
| K181791 | Simplystrong, SimplyezeeGCJ · Traditional | 08/21/2018SE |
| K180836 | GenistrongGCJ · Special | 04/18/2018SE |
| K180579 | Ezee RetrievalGCJ · Special | 03/19/2018SE |
| K171752 | X-SurgeGEI · Special | 10/17/2017SE |
| K162059 | Ezee RetrievalGCJ · Special | 09/29/2016SE |
| K132375 | Genistrong Single-Use Specimen Retrieval BagGCJ · Traditional | 06/12/2014SE |
| K100090 | Implantable ClipFZP · Special | 02/02/2010SE |
| K061417 | Genicon Disposable Electrosurgical Instrumentation, Model 533-005-910GEI · Traditional | 10/10/2006SE |
| K041967 | Genicon Suction Irrigation SystemGCJ · Abbreviated | 11/12/2004SE |
| K041968 | Genicon Bipolar Forceps Model # 600-005-005GEI · Abbreviated | 11/03/2004SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0310-2021 Class II | A Li-Gator Single Use Laparoscopic Clip Applier, 10 mm X 29 cm - Product Usage: intended…Device malfunction causing the applier to jam, and clip loading failures. | 09/17/2020Open, Classified |
| Z-0094-2021 Class II | Aquas PowerFlow Tube Set - Product Usage: The device delivers sterile irrigation fluids…The product design incorporating a motor driven impeller pump powered by one 9V alkaline battery inside the… | 08/25/2020Open, Classified |
| Z-2279-2020 Class II | Genicon Natura Model 210-005-052, 5mm diameter, 70mm length (two cannula, threaded) -…There is potential for the plastic optical tip to become detached from the metal shaft. | 08/21/2018Open, Classified |
| Z-2278-2020 Class II | Genicon GENILook Model 200-105-252, 5mm diameter, 150mm length (2 cannula) - Product…There is potential for the plastic optical tip to become detached from the metal shaft. | 08/21/2018Open, Classified |
| Z-2277-2020 Class II | Genicon Natura Model 210-105-251, 5mm diameter, 150mm length (1 cannula) - Product…There is potential for the plastic optical tip to become detached from the metal shaft. | 08/21/2018Open, Classified |
| Z-2276-2020 Class II | Genicon Natura Model 210-005-251, 5mm diameter, 150mm length (one cannula, threaded) -…There is potential for the plastic optical tip to become detached from the metal shaft. | 08/21/2018Open, Classified |
| Z-2275-2020 Class II | Genicon Natura Model 210-005-152, 5mm diameter, 100mm length (two cannula, threaded) -…There is potential for the plastic optical tip to become detached from the metal shaft. | 08/21/2018Open, Classified |
| Z-2274-2020 Class II | Genicon Natura Model 210-005-151; 5mm diameter, 100mm length (one cannula, threaded) -…There is potential for the plastic optical tip to become detached from the metal shaft. | 08/21/2018Open, Classified |
| Z-2273-2020 Class II | Genicon Natura Model 210-005-051; 5mm diameter, 70mm length (one cannula, threaded) -…There is potential for the plastic optical tip to become detached from the metal shaft. | 08/21/2018Open, Classified |
| Z-2272-2020 Class II | Genicon GENILook Model 200-105-251, 5mm diameter, 150mm length (1 cannula) - Product…There is potential for the plastic optical tip to become detached from the metal shaft. | 08/21/2018Open, Classified |
| Z-2271-2020 Class II | Genicon GENILook Model 200-105-152, 5mm diameter, 100mm length (2 cannula) - Product…There is potential for the plastic optical tip to become detached from the metal shaft. | 08/21/2018Open, Classified |
| Z-2270-2020 Class II | Genicon GENILook Model 200-105-151, 5mm diameter, 100mm length (one cannula) - Product…There is potential for the plastic optical tip to become detached from the metal shaft. | 08/21/2018Open, Classified |
| Z-2269-2020 Class II | Genicon GENILook Model 200-005-251, 5mm diameter, 150mm length (one cannula, threaded) -…There is potential for the plastic optical tip to become detached from the metal shaft. | 08/21/2018Open, Classified |
| Z-2268-2020 Class II | Genicon GENILook Model 200-005-153; 5mm diameter, 100mm length (three cannula) - Product…There is potential for the plastic optical tip to become detached from the metal shaft. | 08/21/2018Open, Classified |
| Z-2267-2020 Class II | Genicon GENILook Model 200-005-152, 5mm diameter, 100mm legnth (2 cannula, threaded) -…There is potential for the plastic optical tip to become detached from the metal shaft. | 08/21/2018Open, Classified |
| Z-2266-2020 Class II | Genicon GENILook Model 200-005-151, 5mm diameter, 100mm length (one cannula, threaded) -…There is potential for the plastic optical tip to become detached from the metal shaft. | 08/21/2018Open, Classified |
| Z-2005-2020 Class II | Genicon EZee Single Use Specimen Retrieval Bag - Product Usage: This device is…Genicon is providing updated IFU labeling to users to provide clarity on how to use the device for multiple… | 06/27/2018Open, Classified |
| Z-1076-2018 Class II | GENICON EZEE Retrieval, sterile, Rx only.Plastic handle is breaking off of shaft inhibiting proper removal per Instructions for Use. | 07/19/2017Terminated |