The following data is part of a premarket notification filed by Meridian Ag with the FDA for Microruptor 6.
| Device ID | K160677 |
| 510k Number | K160677 |
| Device Name: | MICRORUPTOR 6 |
| Classification | Powered Laser Surgical Instrument |
| Applicant | MERIDIAN AG BIERIGUTSTRASSE 7 Thun, CH Ch-3608 |
| Contact | Franziska Gotschi |
| Correspondent | Kevin Walls REGULATORY INSIGHT, INC. 33 GOLDEN EAGLE LANE Littleton, CO 80127 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-10 |
| Decision Date | 2017-05-19 |