The following data is part of a premarket notification filed by Encision, Inc. with the FDA for Suction Irrigation Electrodes And Adapters.
| Device ID | K100711 |
| 510k Number | K100711 |
| Device Name: | SUCTION IRRIGATION ELECTRODES AND ADAPTERS |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ENCISION, INC. 6797 WINCHESTER CIR. Boulder, CO 80301 |
| Contact | Judith V King |
| Correspondent | Daniel W Lehtonen INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2010-03-12 |
| Decision Date | 2010-06-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10815288013881 | K100711 | 000 |
| 10815288013089 | K100711 | 000 |
| 10815288010941 | K100711 | 000 |
| 10815288010903 | K100711 | 000 |