The following data is part of a premarket notification filed by Olympus Surgical Technologies America with the FDA for Cleverlock Guidewire Locking Device And Biopsy Cap.
| Device ID | K190164 |
| 510k Number | K190164 |
| Device Name: | CleverLock Guidewire Locking Device And Biopsy Cap |
| Classification | Endoscope Channel Accessory |
| Applicant | Olympus Surgical Technologies America 136 Turnpike Road Southborough, MA 01772 -2104 |
| Contact | Mary Anne Patella |
| Correspondent | Mary Anne Patella Olympus Surgical Technologies America 136 Turnpike Road Southborough, MA 01772 -2104 |
| Product Code | ODC |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-01-31 |
| Decision Date | 2019-04-04 |