The following data is part of a premarket notification filed by Renovo, Inc. with the FDA for Reprocessed Arthrocare Ent Coblator.
| Device ID | K172647 |
| 510k Number | K172647 |
| Device Name: | Reprocessed ArthroCare ENT Coblator |
| Classification | Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed |
| Applicant | ReNovo, Inc. 340 SW Columbia St Bend, OR 97702 |
| Contact | Mark K. Wells |
| Correspondent | Robert V. Packard Medical Devices Academy, Inc. 345 Lincoln Hill Rd. Shrewsbury, VT 05738 |
| Product Code | NUJ |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-01 |
| Decision Date | 2018-02-21 |
| Summary: | summary |