The following data is part of a premarket notification filed by Encision Inc. with the FDA for Encision Aem Entouch 2x Scissor.
| Device ID | K201018 |
| 510k Number | K201018 |
| Device Name: | Encision AEM EnTouch 2X Scissor |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Encision Inc. 6797 Winchester Circle Boulder, CO 80260 |
| Contact | Pete Geary |
| Correspondent | Pete Geary Encision Inc. 6797 Winchester Circle Boulder, CO 80260 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-04-17 |
| Decision Date | 2020-07-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20815288014021 | K201018 | 000 |
| 20815288014014 | K201018 | 000 |
| 20815288014007 | K201018 | 000 |
| 10815288013997 | K201018 | 000 |