ENDOGATOR
Pump, Air, Non-manual, For Endoscope
BYRNE MEDICAL, INC.
The following data is part of a premarket notification filed by Byrne Medical, Inc. with the FDA for Endogator.
Pre-market Notification Details
| Device ID | K092429 |
| 510k Number | K092429 |
| Device Name: | ENDOGATOR |
| Classification | Pump, Air, Non-manual, For Endoscope |
| Applicant | BYRNE MEDICAL, INC. 3150 POLLOCK DR. Conroe, TX 77303 |
| Contact | Don Byrne |
| Correspondent | Jay Y Kogoma INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | FEQ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-08-07 |
| Decision Date | 2009-11-19 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04961333241774 | K092429 | 000 |
| 04961333241729 | K092429 | 000 |
| 20677964060889 | K092429 | 000 |
| 20677964060322 | K092429 | 000 |
| 20677964060308 | K092429 | 000 |
Trademark Results [ENDOGATOR]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ENDOGATOR 85892004 not registered Dead/Abandoned |
MEDIVATORS Inc. 2013-04-01 |
 ENDOGATOR 85332597 4074236 Live/Registered |
MEDIVATORS INC. 2011-05-27 |
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