The following data is part of a premarket notification filed by Gyrus Acmi, Inc. with the FDA for Pk Cutting Forceps For Esg-400 Workstation.
| Device ID | K142759 |
| 510k Number | K142759 |
| Device Name: | PK Cutting Forceps For ESG-400 Workstation |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | GYRUS ACMI, INC. 136 TURNPIKE RD. Southborough, MA 01772 |
| Contact | Dolan Mills |
| Correspondent | Dolan Mills GYRUS ACMI, INC. 136 TURNPIKE RD. 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 | 2014-09-25 |
| Decision Date | 2015-01-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00821925035850 | K142759 | 000 |