The following data is part of a premarket notification filed by Ent Biotech Solutions with the FDA for Ent Biotech Solutions Tissue Removal Device (elasso).
| Device ID | K152702 |
| 510k Number | K152702 |
| Device Name: | ENT BIOTECH SOLUTIONS TISSUE REMOVAL DEVICE (ELASSO) |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ENT BIOTECH SOLUTIONS 75 LEWISTON ROAD Gross Pointe Farms, MI 48236 |
| Contact | Laura Yamada |
| Correspondent | Laura Yamada ENT BIOTECH SOLUTIONS 75 LEWISTON ROAD Gross Pointe Farms, MI 48236 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-21 |
| Decision Date | 2016-02-18 |
| Summary: | summary |