The following data is part of a premarket notification filed by Interscope, Inc. with the FDA for Endorotor Console, Endorotor Catheters, Endorotor Specimen Trap, Endorotor Filter Set, Endorotor Foot Control.
| Device ID | K181127 |
| 510k Number | K181127 |
| Device Name: | EndoRotor Console, EndoRotor Catheters, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Foot Control |
| Classification | Endoscopic Morcellator Gastroenterology |
| 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 | PTE |
| CFR Regulation Number | 884.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-30 |
| Decision Date | 2019-01-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00854172008254 | K181127 | 000 |