FAT — Bougie, Esophageal, And Gastrointestinal, Gastro-Urology Class II
FDA Device Classification
Classification Details
- Product Code
- FAT
- Device Class
- Class II
- Regulation Number
- 876.5365
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K133439 | teleflexmedical | PILLING ESOPHAGEAL BOUGIES | June 16, 2014 |
| K983220 | stryker endoscopy | STRYKER INFRAVISION ESOPHAGEAL KIT | June 4, 1999 |
| K972119 | medovations | MALONEY BOUGE (1210-XX)/HURST BOUGIE (1212-XX) | February 2, 1998 |
| K960173 | gabriel medical | INFRA VISION BOUGIE KIT, INFRA VISION ESOPHAGEAL KIT | June 27, 1996 |
| K901425 | telemed systems | PYLORIC BALLOON DILATOR | June 21, 1990 |
| K843186 | dacomed | ESKA MULTISTAGE ESOPHAGEAL BOUGIE | January 18, 1985 |
| K842679 | mill-rose laboratory | ESOPHAGEAL DILATOR SET | October 2, 1984 |
| K780471 | gaymar industries | GASTRIC LAVAGE KIT | June 2, 1978 |