The following data is part of a premarket notification filed by Byrne Medical, Inc. with the FDA for Endogater Avantage Co2 Insufflator.
| Device ID | K113310 |
| 510k Number | K113310 |
| Device Name: | ENDOGATER AVANTAGE CO2 INSUFFLATOR |
| Classification | Insufflator, Automatic Carbon-dioxide For Endoscope |
| 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 | FCX |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-08 |
| Decision Date | 2012-06-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04961333242979 | K113310 | 000 |
| 04961333242962 | K113310 | 000 |
| 04961333242955 | K113310 | 000 |
| 04961333242948 | K113310 | 000 |
| 04961333242931 | K113310 | 000 |
| 30677964085568 | K113310 | 000 |
| 30677964085575 | K113310 | 000 |
| 00677964063671 | K113310 | 000 |