The following data is part of a premarket notification filed by Steris Corporation with the FDA for Endoscope Tip Protector - Sterile, Endoscope Tip Protector - Non-sterile.
| Device ID | K191715 |
| 510k Number | K191715 |
| Device Name: | Endoscope Tip Protector - Sterile, Endoscope Tip Protector - Non-sterile |
| Classification | Endoscopic Storage Cover |
| Applicant | STERIS Corporation 5976 Heisley Road Mentor, OH 44060 |
| Contact | Jennifer Nalepka |
| Correspondent | Jennifer Nalepka STERIS Corporation 5960 Heisley Road Mentor, OH 44060 |
| Product Code | OCU |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-26 |
| Decision Date | 2020-01-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10724995190641 | K191715 | 000 |
| 10724995190634 | K191715 | 000 |