The following data is part of a premarket notification filed by Gyrx, Llc with the FDA for Visu-lock 5mm Clip Applier.
| Device ID | K033161 |
| 510k Number | K033161 |
| Device Name: | VISU-LOCK 5MM CLIP APPLIER |
| Classification | Clip, Implantable |
| Applicant | GYRX, LLC 11222 ST. JOHNS INDUSTRIAL PARKWAY N. Jacksonville, FL 32246 |
| Contact | Cory Edwards |
| Correspondent | Cory Edwards GYRX, LLC 11222 ST. JOHNS INDUSTRIAL PARKWAY N. Jacksonville, FL 32246 |
| Product Code | FZP |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-30 |
| Decision Date | 2003-12-18 |
| Summary: | summary |