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Encision, Inc.

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
10
Inspections
4
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1951-2012Class IIAEM Disposable Electrodes, Device, Electrosurgical, Cutting and Coagulation and Accessories. AEM DiJune 15, 2012

Recent 510(k) Clearances

K-NumberDeviceDate
K201018Encision AEM enTouch 2X ScissorJuly 15, 2020
K140006ENDOSHIELD BURN PROTECTION SYSTEMJune 16, 2014
K131949AEM DISPOSABLE SUCTION IRRIGATION ELECTRODESAugust 26, 2013
K122383EM3 AEM MONITOR AEM CONNECTORSJanuary 10, 2013
K122580AEM DISPOSABLE SUCTION IRRIGATION HANDSET MODEL ES1700; AEM DISPOSABLE SUCTION IRRIGATION ELECTRODESNovember 9, 2012
K093622AEM MONITORING SYSTEM, MODELS EM2, EMR, ES4007, ES4107, ES9005 AND ES9015August 20, 2010
K100711SUCTION IRRIGATION ELECTRODES AND ADAPTERSJune 9, 2010
K091074AEM DISPOSABLE ELECTRODES,MODEL ESO300 SERIESAugust 17, 2009
K090979DISPOSABLE HANDLE ASSEMBLES, MODELS DH0100 AND DH0500 SERIESMay 28, 2009
K072789DISPOSABLE AEM FIXED TIP ELECTRODES AND HANDPIECESOctober 19, 2007