GastroFlush
Tubes, Gastrointestinal (and Accessories)
Bionix Development Corporation
The following data is part of a premarket notification filed by Bionix Development Corporation with the FDA for Gastroflush.
Pre-market Notification Details
| Device ID | K180605 |
| 510k Number | K180605 |
| Device Name: | GastroFlush |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | Bionix Development Corporation 5154 Enterprise Blvd. Toledo, OH 43612 |
| Contact | James Huttner |
| Correspondent | James Huttner Bionix Development Corporation 5154 Enterprise Blvd. Toledo, OH 43612 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-07 |
| Decision Date | 2018-10-24 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00859911004917 | K180605 | 000 |
Trademark Results [GastroFlush]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GASTROFLUSH 87339646 5703877 Live/Registered |
Bionix Development Corporation 2017-02-17 |
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