The following data is part of a premarket notification filed by Gyrus Acmi, Inc. with the FDA for Gyrus Acmil Bipolarlaproscopic Loop (pks Bill).
| Device ID | K111059 |
| 510k Number | K111059 |
| Device Name: | GYRUS ACMIL BIPOLARLAPROSCOPIC LOOP (PKS BILL) |
| Classification | Coagulator-cutter, Endoscopic, Bipolar (and Accessories) |
| Applicant | GYRUS ACMI, INC. 136 TURNPIKE RD. Southborough, MA 01772 |
| Contact | Lorraine Calzetta |
| Correspondent | Lorraine Calzetta GYRUS ACMI, INC. 136 TURNPIKE RD. Southborough, MA 01772 |
| Product Code | HIN |
| CFR Regulation Number | 884.4150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-04-18 |
| Decision Date | 2011-09-01 |
| Summary: | summary |