The following data is part of a premarket notification filed by Steris Corporation with the FDA for Padlock Clip Defect Closure Device; Padlock Clip Pro-select Defect Closure Device.
| Device ID | K180689 |
| 510k Number | K180689 |
| Device Name: | Padlock Clip Defect Closure Device; Padlock Clip Pro-Select Defect Closure Device |
| Classification | Hemostatic Metal Clip For The Gi Tract |
| Applicant | STERIS Corporation 5976 Heisley Road Mentor, OH 44060 |
| Contact | Tony Piotrkowski |
| Correspondent | Tony Piotrkowski STERIS Corporation 5976 Heisley Road Mentor, OH 44060 |
| Product Code | PKL |
| CFR Regulation Number | 876.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-15 |
| Decision Date | 2018-04-12 |
| Summary: | summary |