Medical Device Manufacturer · US , Boulder , CO

Encision, Inc. - FDA 510(k) Cleared Devices

10 submissions · 10 cleared · Since 2007

Recent clearances: Encision AEM enTouch 2X Scissor

Official Website

10

Total

10

Cleared

0

Denied

FDA 510(k) Regulatory Record - Encision, Inc. General & Plastic Surgery ✕

10 devices

1-10 of 10

Cleared Jul 15, 2020

Encision AEM enTouch 2X Scissor

General & Plastic Surgery · 89d

Cleared Jun 16, 2014

ENDOSHIELD BURN PROTECTION SYSTEM

General & Plastic Surgery · 165d

Cleared Aug 26, 2013

AEM DISPOSABLE SUCTION IRRIGATION ELECTRODES

General & Plastic Surgery · 60d

Cleared Jan 10, 2013

EM3 AEM MONITOR AEM CONNECTORS

General & Plastic Surgery · 157d

Cleared Nov 09, 2012

AEM DISPOSABLE SUCTION IRRIGATION HANDSET MODEL ES1700

General & Plastic Surgery · 78d

Cleared Aug 20, 2010

AEM MONITORING SYSTEM, MODELS EM2, EMR, ES4007, ES4107, ES9005 AND ES9015

General & Plastic Surgery · 270d

Cleared Jun 09, 2010

SUCTION IRRIGATION ELECTRODES AND ADAPTERS

General & Plastic Surgery · 89d

Cleared Aug 17, 2009

AEM DISPOSABLE ELECTRODES,MODEL ESO300 SERIES

General & Plastic Surgery · 125d

Cleared May 28, 2009

DISPOSABLE HANDLE ASSEMBLES, MODELS DH0100 AND DH0500 SERIES

General & Plastic Surgery · 51d

Cleared Oct 19, 2007

DISPOSABLE AEM FIXED TIP ELECTRODES AND HANDPIECES

General & Plastic Surgery · 18d