Genicon, Inc.

FDA Regulatory Profile

Summary

Total Recalls
18
510(k) Clearances
11
Inspections
5
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0310-2021Class IIA Li-Gator Single Use Laparoscopic Clip Applier, 10 mm X 29 cm - Product Usage: intended for use on September 17, 2020
Z-0094-2021Class IIAquas PowerFlow Tube Set - Product Usage: The device delivers sterile irrigation fluids to surgical August 25, 2020
Z-2274-2020Class IIGenicon Natura Model 210-005-151; 5mm diameter, 100mm length (one cannula, threaded) - Product UsageAugust 21, 2018
Z-2277-2020Class IIGenicon Natura Model 210-105-251, 5mm diameter, 150mm length (1 cannula) - Product Usage: The univerAugust 21, 2018
Z-2272-2020Class IIGenicon GENILook Model 200-105-251, 5mm diameter, 150mm length (1 cannula) - Product Usage: The univAugust 21, 2018
Z-2269-2020Class IIGenicon GENILook Model 200-005-251, 5mm diameter, 150mm length (one cannula, threaded) - Product UsaAugust 21, 2018
Z-2271-2020Class IIGenicon GENILook Model 200-105-152, 5mm diameter, 100mm length (2 cannula) - Product Usage: The univAugust 21, 2018
Z-2273-2020Class IIGenicon Natura Model 210-005-051; 5mm diameter, 70mm length (one cannula, threaded) - Product Usage:August 21, 2018
Z-2276-2020Class IIGenicon Natura Model 210-005-251, 5mm diameter, 150mm length (one cannula, threaded) - Product UsageAugust 21, 2018
Z-2267-2020Class IIGenicon GENILook Model 200-005-152, 5mm diameter, 100mm legnth (2 cannula, threaded) - Product UsageAugust 21, 2018
Z-2268-2020Class IIGenicon GENILook Model 200-005-153; 5mm diameter, 100mm length (three cannula) - Product Usage: The August 21, 2018
Z-2266-2020Class IIGenicon GENILook Model 200-005-151, 5mm diameter, 100mm length (one cannula, threaded) - Product UsaAugust 21, 2018
Z-2279-2020Class IIGenicon Natura Model 210-005-052, 5mm diameter, 70mm length (two cannula, threaded) - Product Usage:August 21, 2018
Z-2275-2020Class IIGenicon Natura Model 210-005-152, 5mm diameter, 100mm length (two cannula, threaded) - Product UsageAugust 21, 2018
Z-2278-2020Class IIGenicon GENILook Model 200-105-252, 5mm diameter, 150mm length (2 cannula) - Product Usage: The univAugust 21, 2018
Z-2270-2020Class IIGenicon GENILook Model 200-105-151, 5mm diameter, 100mm length (one cannula) - Product Usage: The unAugust 21, 2018
Z-2005-2020Class IIGenicon EZee Single Use Specimen Retrieval Bag - Product Usage: This device is disposable and is pacJune 27, 2018
Z-1076-2018Class IIGENICON EZEE Retrieval, sterile, Rx only.July 19, 2017

Recent 510(k) Clearances

K-NumberDeviceDate
K190168Aquas ProbesMarch 14, 2019
K181791SIMPLYSTRONG, SIMPLYEZEEAugust 21, 2018
K180836GenistrongApril 18, 2018
K180579Ezee RetrievalMarch 19, 2018
K171752X-SURGEOctober 17, 2017
K162059EZEE RETRIEVALSeptember 29, 2016
K132375GENISTRONG SINGLE-USE SPECIMEN RETRIEVAL BAGJune 12, 2014
K100090IMPLANTABLE CLIPFebruary 2, 2010
K061417GENICON DISPOSABLE ELECTROSURGICAL INSTRUMENTATION, MODEL 533-005-910October 10, 2006
K041967GENICON SUCTION IRRIGATION SYSTEMNovember 12, 2004
K041968GENICON BIPOLAR FORCEPS MODEL # 600-005-005November 3, 2004