Standard Bougie
Tubes, Gastrointestinal (and Accessories)
Standard Bariatrics
The following data is part of a premarket notification filed by Standard Bariatrics with the FDA for Standard Bougie.
Pre-market Notification Details
| Device ID | K191885 |
| 510k Number | K191885 |
| Device Name: | Standard Bougie |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | Standard Bariatrics 4362 Glendale Milford Rd. Cincinnati, OH 45242 |
| Contact | Alison Sathe |
| Correspondent | Alison Sathe Standard Bariatrics 4362 Glendale Milford Rd. Cincinnati, OH 45242 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-15 |
| Decision Date | 2020-04-08 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10851677007055 | K191885 | 000 |
Trademark Results [Standard Bougie]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 STANDARD BOUGIE 88877997 not registered Live/Pending |
Standard Bariatrics, Inc. 2020-04-19 |
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