Genicon, Inc.
Maitland, FL, US
Genicon, Inc. appears in FDA device records in Maitland, FL. FDA records list 11 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 21 recalls for this company.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Genicon, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Genico, Inc., dba Geniconrecall
510(k) clearance history
FDA records hold 11 510(k) clearances for Genicon, Inc. between 2004 and 2019. The busiest year on record is 2018, with 3. The most recent is 2019, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2004 | 2 |
| 2006 | 1 |
| 2010 | 1 |
| 2014 | 1 |
| 2016 | 1 |
| 2017 | 1 |
| 2018 | 3 |
| 2019 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K190168 | Aquas Probes | GEI | Substantially Equivalent | |
| K181791 | SIMPLYSTRONG, SIMPLYEZEE | GCJ | Substantially Equivalent | |
| K180836 | Genistrong | GCJ | Substantially Equivalent | |
| K180579 | Ezee Retrieval | GCJ | Substantially Equivalent | |
| K171752 | X-SURGE | GEI | Substantially Equivalent | |
| K162059 | EZEE RETRIEVAL | GCJ | Substantially Equivalent | |
| K132375 | GENISTRONG SINGLE-USE SPECIMEN RETRIEVAL BAG | GCJ | Substantially Equivalent | |
| K100090 | IMPLANTABLE CLIP | FZP | Substantially Equivalent | |
| K061417 | GENICON DISPOSABLE ELECTROSURGICAL INSTRUMENTATION, MODEL 533-005-910 | GEI | Substantially Equivalent | |
| K041967 | GENICON SUCTION IRRIGATION SYSTEM | GCJ | Substantially Equivalent | |
| K041968 | GENICON BIPOLAR FORCEPS MODEL # 600-005-005 | GEI | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0310-2021 | A Li-Gator Single Use Laparoscopic Clip Applier, 10 mm X 29 cm - Product Usage: intended for use on tubular structures or vessel wherever a metal litigating clip is intended | Device malfunction causing the applier to jam, and clip loading failures. | Class II | Open, Classified | |
| Z-0094-2021 | Aquas PowerFlow Tube Set - Product Usage: The device delivers sterile irrigation fluids to surgical sites during laparoscopic procedures and to evacuate blood, tissue debris, and smoke from the surgical site | 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). | Class II | Open, Classified | |
| Z-2279-2020 | Genicon Natura Model 210-005-052, 5mm diameter, 70mm length (two cannula, threaded) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope. | There is potential for the plastic optical tip to become detached from the metal shaft. | Class II | Open, Classified | |
| Z-2278-2020 | Genicon GENILook Model 200-105-252, 5mm diameter, 150mm length (2 cannula) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope. | There is potential for the plastic optical tip to become detached from the metal shaft. | Class II | Open, Classified | |
| Z-2277-2020 | Genicon Natura Model 210-105-251, 5mm diameter, 150mm length (1 cannula) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope. | There is potential for the plastic optical tip to become detached from the metal shaft. | Class II | Open, Classified | |
| Z-2276-2020 | Genicon Natura Model 210-005-251, 5mm diameter, 150mm length (one cannula, threaded) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope. | There is potential for the plastic optical tip to become detached from the metal shaft. | Class II | Open, Classified | |
| Z-2275-2020 | Genicon Natura Model 210-005-152, 5mm diameter, 100mm length (two cannula, threaded) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope. | There is potential for the plastic optical tip to become detached from the metal shaft. | Class II | Open, Classified | |
| Z-2274-2020 | Genicon Natura Model 210-005-151; 5mm diameter, 100mm length (one cannula, threaded) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope. | There is potential for the plastic optical tip to become detached from the metal shaft. | Class II | Open, Classified | |
| Z-2273-2020 | Genicon Natura Model 210-005-051; 5mm diameter, 70mm length (one cannula, threaded) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope. | There is potential for the plastic optical tip to become detached from the metal shaft. | Class II | Open, Classified | |
| Z-2272-2020 | Genicon GENILook Model 200-105-251, 5mm diameter, 150mm length (1 cannula) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope. | There is potential for the plastic optical tip to become detached from the metal shaft. | Class II | Open, Classified | |
| Z-2271-2020 | Genicon GENILook Model 200-105-152, 5mm diameter, 100mm length (2 cannula) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope. | There is potential for the plastic optical tip to become detached from the metal shaft. | Class II | Open, Classified | |
| Z-2270-2020 | Genicon GENILook Model 200-105-151, 5mm diameter, 100mm length (one cannula) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope. | There is potential for the plastic optical tip to become detached from the metal shaft. | Class II | Open, Classified | |
| Z-2269-2020 | Genicon GENILook Model 200-005-251, 5mm diameter, 150mm length (one cannula, threaded) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope. | There is potential for the plastic optical tip to become detached from the metal shaft. | Class II | Open, Classified | |
| Z-2268-2020 | Genicon GENILook Model 200-005-153; 5mm diameter, 100mm length (three cannula) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope. | There is potential for the plastic optical tip to become detached from the metal shaft. | Class II | Open, Classified | |
| Z-2267-2020 | Genicon GENILook Model 200-005-152, 5mm diameter, 100mm legnth (2 cannula, threaded) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope. | There is potential for the plastic optical tip to become detached from the metal shaft. | Class II | Open, Classified | |
| Z-2266-2020 | Genicon GENILook Model 200-005-151, 5mm diameter, 100mm length (one cannula, threaded) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope. | There is potential for the plastic optical tip to become detached from the metal shaft. | Class II | Open, Classified | |
| Z-2005-2020 | Genicon EZee Single Use Specimen Retrieval Bag - Product Usage: This device is disposable and is packaged and sterilized for single use only. The bag may be used for multiple specimen retraction. | Genicon is providing updated IFU labeling to users to provide clarity on how to use the device for multiple specimen retrieval. | Class II | Open, Classified | |
| Z-1076-2018 | GENICON EZEE Retrieval, sterile, Rx only. | Plastic handle is breaking off of shaft inhibiting proper removal per Instructions for Use. | Class II | Terminated | |
| Z-0622-2009 | Genicon 5mm Pyramidal Trocar, Sterile, Genion 6869 Stapoint Court, Suite 114 Winter Park, FL U.S.A. 32792, Rx Only. Catalog Numbers: 100-005-001 & 100-005-002. Used for incisions made for positioning the laparoscopic cannulas or ports. | 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. | Terminated | ||
| Z-1957-2009 | Genicon, RX Only, Sterile EO. Genicon 6869 Stapoint Court, Suite 114 Winter Park, FL U.S.A. 32792. EC REP Genicon Europe, Ltd. 44 Airedale Avenue, Chiswick London U.K. W4 2NW. Catalog Number 700-010-005, 10MM (Foreign Distribution Only). A suction irrigation device. This device is used in conjunction with an insufflator during laparoscopic surgery to provide suction and irrigation to the surgical site. The suction irrigation product contains a trumpet valve handpiece that fits into either the left or right hand. The double sealing valve system provides operation of the suction and irrigation functions while preventing fluid leakage. | Genicon is recalling the Genicon Disposable Suction Irrigation 5mm 700-005-010 and 10mm 700-005-005 Tube Sets. The caps on the trumpet valves of the devices could fall off, resulting in the malfunction of the Suction Irrigation Device. | Terminated | ||
| Z-1956-2009 | Genicon, RX Only, Sterile EO. Genicon 6869 Stapoint Court, Suite 114 Winter Park, FL U.S.A. 32792. EC REP Genicon Europe, Ltd. 44 Airedale Avenue, Chiswick London U.K. W4 2NW. Catalog Number 700-005-010, 5MM. A suction irrigation device. This device is used in conjunction with an insufflator during laparoscopic surgery to provide suction and irrigation to the surgical site. The suction irrigation product contains a trumpet valve handpiece that fits into either the left or right hand. The double sealing valve system provides operation of the suction and irrigation functions while preventing fluid leakage. | Genicon is recalling the Genicon Disposable Suction Irrigation 5mm 700-005-010 and 10mm 700-005-005 Tube Sets. The caps on the trumpet valves of the devices could fall off, resulting in the malfunction of the Suction Irrigation Device. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain