The following data is part of a premarket notification filed by Steris Corporation with the FDA for Endogator Endoscopy Irrigation Tubing.
| Device ID | K220395 |
| 510k Number | K220395 |
| Device Name: | EndoGator Endoscopy Irrigation Tubing |
| Classification | Pump, Air, Non-manual, For Endoscope |
| Applicant | STERIS Corporation 5960 Heisley Road Mentor, OH 44060 |
| Contact | Carroll Martin |
| Correspondent | Carroll Martin STERIS Corporation 5960 Heisley Road Mentor, OH 44060 |
| Product Code | FEQ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-02-11 |
| Decision Date | 2022-03-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816765013434 | K220395 | 000 |