The following data is part of a premarket notification filed by Microline Surgical, Inc. with the FDA for Renew V Handpiece Laparoscopic Instruments.
| Device ID | K160706 |
| 510k Number | K160706 |
| Device Name: | ReNew V Handpiece Laparoscopic Instruments |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | MICROLINE SURGICAL, INC. 50 DUNHAM ROAD, SUITE 1500 Beverly, MA 01915 |
| Contact | Anu Gaur |
| Correspondent | Anu Gaur 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 | 2016-03-14 |
| Decision Date | 2016-10-19 |
| Summary: | summary |