The following data is part of a premarket notification filed by Gyrus Acmi, Inc. with the FDA for Gyrus Amci Pk Button Electrode.
| Device ID | K120567 |
| 510k Number | K120567 |
| Device Name: | GYRUS AMCI PK BUTTON ELECTRODE |
| Classification | Electrode, Electrosurgical, Active, Urological |
| Applicant | GYRUS ACMI, INC. 136 TURNPIKE RD. Southborough, MA 01772 |
| Contact | Neil Kelly |
| Correspondent | Neil Kelly GYRUS ACMI, INC. 136 TURNPIKE RD. Southborough, MA 01772 |
| Product Code | FAS |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-02-27 |
| Decision Date | 2012-06-20 |
| Summary: | summary |