The following data is part of a premarket notification filed by Byrne Medical, Inc. with the FDA for Endo Gator System.
| Device ID | K031773 |
| 510k Number | K031773 |
| Device Name: | ENDO GATOR SYSTEM |
| Classification | Endoscopic Irrigation/suction System |
| Applicant | BYRNE MEDICAL, INC. 11874 SOUTH EVELYN CIRCLE Houston, TX 77071 |
| Contact | J. Harvey Knauss |
| Correspondent | Ned Devine ENTELA, INC. 3033 MADISON AVENUE, SE Grand Rapids, MI 49548 |
| Product Code | OCX |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2003-06-09 |
| Decision Date | 2003-06-24 |
| Summary: | summary |