| Device Type ID | 1731 |
| Device Name | Bougie, Esophageal, And Gastrointestinal, Gastro-urology |
| Regulation Description | Esophageal Dilator. |
| Regulation Medical Specialty | Gastroenterology/Urology |
| Review Panel | Gastroenterology/Urology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Gastroenterology Devices Branch (GEDB) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 876.5365 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | FAT |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
| Device Type ID | 1731 |
| Device | Bougie, Esophageal, And Gastrointestinal, Gastro-urology |
| Product Code | FAT |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Esophageal Dilator. |
| CFR Regulation Number | 876.5365 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
TELEFLEX MEDICAL | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TELEFLEX MEDICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Use Of Device Problem | 2 |
Adverse Event Without Identified Device Or Use Problem | 1 |
| Total Device Problems | 3 |