The following data is part of a premarket notification filed by Byrne Medical, Inc. with the FDA for Endogator Advantage Irrigation Pump.
| Device ID | K113119 |
| 510k Number | K113119 |
| Device Name: | ENDOGATOR ADVANTAGE IRRIGATION PUMP |
| Classification | Endoscopic Irrigation/suction System |
| Applicant | BYRNE MEDICAL, INC. 14605 28TH AVENUE NORTH Minneapolis, MN 55442 |
| Contact | Brent Geiger |
| Correspondent | Brent Geiger BYRNE MEDICAL, INC. 14605 28TH AVENUE NORTH Minneapolis, MN 55442 |
| Product Code | OCX |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-10-21 |
| Decision Date | 2012-04-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04961333242993 | K113119 | 000 |
| 04961333242986 | K113119 | 000 |
| 04961333242924 | K113119 | 000 |
| 30677964085537 | K113119 | 000 |
| 30677964083632 | K113119 | 000 |
| 00677964063664 | K113119 | 000 |