The following data is part of a premarket notification filed by Microline Surgical, Inc. with the FDA for Renew Disposable Scissor Tips.
| Device ID | K213127 |
| 510k Number | K213127 |
| Device Name: | ReNew Disposable Scissor Tips |
| 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 | 2021-09-27 |
| Decision Date | 2022-03-02 |