The following data is part of a premarket notification filed by Microline Surgical, Inc. with the FDA for Renew Xr Handpiece, Renew Xr Handpiece 34cm, Renew Xr Handpiece 42cm, Renew Xr Handpiece 25cm, Ratcheted Renew Xr Handpiece 34cm.
| Device ID | K201884 |
| 510k Number | K201884 |
| Device Name: | ReNew XR Handpiece, ReNew XR Handpiece 34cm, ReNew XR Handpiece 42cm, ReNew XR Handpiece 25cm, Ratcheted ReNew XR Handpiece 34cm |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Microline Surgical, Inc. 50 Dunham Road, Suite 1500 Beverly, MA 01915 |
| Contact | Scott Marchand Davis |
| Correspondent | Scott Marchand Davis Microline Surgical, Inc. 50 Dunham Road, Suite 1500 Beverly, MA 01915 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-08 |
| Decision Date | 2020-10-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811099013815 | K201884 | 000 |
| 00811099013839 | K201884 | 000 |
| 00811099013846 | K201884 | 000 |
| 00811099013853 | K201884 | 000 |
| 00811099013761 | K201884 | 000 |
| 00811099013778 | K201884 | 000 |
| 00811099013785 | K201884 | 000 |
| 00811099013792 | K201884 | 000 |
| 00811099013808 | K201884 | 000 |
| 00811099013822 | K201884 | 000 |