The following data is part of a premarket notification filed by Gyrus Acmi Inc. with the FDA for Pk Aim.
| Device ID | K170908 |
| 510k Number | K170908 |
| Device Name: | PK AIM |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Gyrus ACMI Inc. 136 Turnpike Road Southborough, MA 01772 |
| Contact | Graham A. L. Baillie |
| Correspondent | Graham A. L. Baillie GYRUS ENT L.L.C., SUB. OF GYRUS ACMI, INC. 136 Turnpike Road Southborough, MA 01772 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-28 |
| Decision Date | 2017-05-19 |
| Summary: | summary |