The following data is part of a premarket notification filed by Interscope, Inc. with the FDA for Endorotor Console, Endorotor Catheter, Endorotor Specimen Trap, Endorotor Filter Set, Endorotor Roll Stand.
| Device ID | K190715 |
| 510k Number | K190715 |
| Device Name: | EndoRotor Console, EndoRotor Catheter, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Roll Stand |
| Classification | Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece |
| Applicant | Interscope, Inc. 100 Main Street, Suite 108 Whitinsville, MA 01588 |
| Contact | Jeffery Ryan |
| Correspondent | Cynthia Nolte ICON Clinical Research, LLC 2100 Pennbrook Parkway North Wales, PA 19454 |
| Product Code | ERL |
| CFR Regulation Number | 874.4250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-19 |
| Decision Date | 2019-12-13 |