The following data is part of a premarket notification filed by Byrne Medical Incorporated with the FDA for Defendo Y-opsy Irrigator.
| Device ID | K110088 |
| 510k Number | K110088 |
| Device Name: | DEFENDO Y-OPSY IRRIGATOR |
| Classification | Endoscope Channel Accessory |
| Applicant | BYRNE MEDICAL INCORPORATED 3150 Pollok Drive Conroe, TX 77303 |
| Contact | John Willis |
| Correspondent | John Willis BYRNE MEDICAL INCORPORATED 3150 Pollok Drive Conroe, TX 77303 |
| Product Code | ODC |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-01-12 |
| Decision Date | 2011-06-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00677964060281 | K110088 | 000 |