The following data is part of a premarket notification filed by Encision, Inc. with the FDA for Aem Disposable Suction Irrigation Handset Model Es1700; Aem Disposable Suction Irrigation Electrodes Model Es077x Series.
| Device ID | K122580 |
| 510k Number | K122580 |
| Device Name: | AEM DISPOSABLE SUCTION IRRIGATION HANDSET MODEL ES1700; AEM DISPOSABLE SUCTION IRRIGATION ELECTRODES MODEL ES077X SERIES |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ENCISION, INC. 6797 WINCHESTER CIR. Boulder, CO 80301 |
| Contact | Jim Lewis |
| Correspondent | Jim Lewis ENCISION, INC. 6797 WINCHESTER CIR. Boulder, CO 80301 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-23 |
| Decision Date | 2012-11-09 |
| Summary: | summary |