Encision, Inc.
FDA Regulatory Profile
Encision, Inc. appears in FDA public data with 1 recall, 10 510(k) clearances, 4 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1951-2012, Class II) was initiated on June 15, 2012. Its most recent 510(k) clearance was granted on July 15, 2020.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 10
- Inspections
- 4
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1951-2012 | Class II | AEM Disposable Electrodes, Device, Electrosurgical, Cutting and Coagulation and Accessories. AEM Di | June 15, 2012 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K201018 | Encision AEM enTouch 2X Scissor | July 15, 2020 |
| K140006 | ENDOSHIELD BURN PROTECTION SYSTEM | June 16, 2014 |
| K131949 | AEM DISPOSABLE SUCTION IRRIGATION ELECTRODES | August 26, 2013 |
| K122383 | EM3 AEM MONITOR AEM CONNECTORS | January 10, 2013 |
| K122580 | AEM DISPOSABLE SUCTION IRRIGATION HANDSET MODEL ES1700; AEM DISPOSABLE SUCTION IRRIGATION ELECTRODES | November 9, 2012 |
| K093622 | AEM MONITORING SYSTEM, MODELS EM2, EMR, ES4007, ES4107, ES9005 AND ES9015 | August 20, 2010 |
| K100711 | SUCTION IRRIGATION ELECTRODES AND ADAPTERS | June 9, 2010 |
| K091074 | AEM DISPOSABLE ELECTRODES,MODEL ESO300 SERIES | August 17, 2009 |
| K090979 | DISPOSABLE HANDLE ASSEMBLES, MODELS DH0100 AND DH0500 SERIES | May 28, 2009 |
| K072789 | DISPOSABLE AEM FIXED TIP ELECTRODES AND HANDPIECES | October 19, 2007 |