Company ยท US
Genicon, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2004 to 2019. Name variants (Inc, Corp, punctuation) are merged.
11510(k) clearances (0 in 12 months)
18recalls (0 in 12 months)
17recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 14, 2019 | K190168 | Aquas Probes Genicon, Inc. | GEI |
| Aug 21, 2018 | K181791 | SIMPLYSTRONG, SIMPLYEZEE Genicon, Inc. | GCJ |
| Apr 18, 2018 | K180836 | Genistrong Genicon, Inc. | GCJ |
| Mar 19, 2018 | K180579 | Ezee Retrieval Genicon, Inc. | GCJ |
| Oct 17, 2017 | K171752 | X-SURGE Genicon, Inc. | GEI |
| Sep 29, 2016 | K162059 | EZEE RETRIEVAL Genicon, Inc. | GCJ |
| Jun 12, 2014 | K132375 | GENISTRONG SINGLE-USE SPECIMEN RETRIEVAL BAG Genicon | GCJ |
| Feb 2, 2010 | K100090 | IMPLANTABLE CLIP Genicon | FZP |
| Oct 10, 2006 | K061417 | GENICON DISPOSABLE ELECTROSURGICAL INSTRUMENTATION, MODEL 533-005-910 Genicon | GEI |
| Nov 12, 2004 | K041967 | GENICON SUCTION IRRIGATION SYSTEM Genicon | GCJ |
| Nov 3, 2004 | K041968 | GENICON BIPOLAR FORCEPS MODEL # 600-005-005 Genicon | GEI |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 17, 2020 | Genicon, Inc. 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 Open, Classified |
FZP | K030269 |
| Aug 25, 2020 | Genicon, Inc. 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 surgic Open, Classified |
N/A | None listed |
| Aug 21, 2018 | Genicon, Inc. 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 Open, Classified |
GEA | K982472 |
| Aug 21, 2018 | Genicon, Inc. 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. Open, Classified |
GEA | K982472 |
| Aug 21, 2018 | Genicon, Inc. 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. Open, Classified |
GEA | K982472 |
| Aug 21, 2018 | Genicon, Inc. 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 Open, Classified |
GEA | K982472 |
| Aug 21, 2018 | Genicon, Inc. 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 Open, Classified |
GEA | K982472 |
| Aug 21, 2018 | Genicon, Inc. 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 Open, Classified |
GEA | K982472 |
| Aug 21, 2018 | Genicon, Inc. 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 Open, Classified |
GEA | K982472 |
| Aug 21, 2018 | Genicon, Inc. 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. Open, Classified |
GEA | K982472 |
| Aug 21, 2018 | Genicon, Inc. 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. Open, Classified |
GEA | K982472 |
| Aug 21, 2018 | Genicon, Inc. 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 Open, Classified |
GEA | K982472 |
| Aug 21, 2018 | Genicon, Inc. 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 usi Open, Classified |
GEA | K982472 |
| Aug 21, 2018 | Genicon, Inc. 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 sco Open, Classified |
GEA | K982472 |
| Aug 21, 2018 | Genicon, Inc. 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 Open, Classified |
GEA | K982472 |
| Aug 21, 2018 | Genicon, Inc. 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 usi Open, Classified |
GEA | K982472 |
| Jun 27, 2018 | Genicon, Inc. 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. Open, Classified |
GCJ | K180579 |
| Jul 19, 2017 | Genicon, Inc. GENICON EZEE Retrieval, sterile, Rx only. Terminated |
GCJ | K162059 |