EndoRotor
Endoscopic Morcellator Gastroenterology
Interscope, Inc
The following data is part of a premarket notification filed by Interscope, Inc with the FDA for Endorotor.
Pre-market Notification Details
| Device ID | K170120 |
| 510k Number | K170120 |
| Device Name: | EndoRotor |
| Classification | Endoscopic Morcellator Gastroenterology |
| Applicant | Interscope, Inc 100 Grove Street, Suite 108 Worchester, MA 01605 |
| Contact | Jeffrey 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 | 2017-01-13 |
| Decision Date | 2017-04-18 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00865830000268 | K170120 | 000 |
| 00865830000213 | K170120 | 000 |
| 00865830000206 | K170120 | 000 |
Trademark Results [EndoRotor]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ENDOROTOR 86447058 5423689 Live/Registered |
Interscope, Inc. 2014-11-06 |
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