Product code FAT
- Device name
- Bougie, Esophageal, And Gastrointestinal, Gastro-Urology
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.5365
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K133439 | PILLING ESOPHAGEAL BOUGIES | Teleflexmedical, Inc. | 2014-06-16 |
| K983220 | STRYKER INFRAVISION ESOPHAGEAL KIT | Stryker Endoscopy | 1999-06-04 |
| K972119 | MALONEY BOUGE (1210-XX)/HURST BOUGIE (1212-XX) | Medovations, Inc. | 1998-02-02 |
| K960173 | INFRA VISION BOUGIE KIT, INFRA VISION ESOPHAGEAL KIT | Gabriel Medical, Inc. | 1996-06-27 |
| K901425 | PYLORIC BALLOON DILATOR | Telemed Systems, Inc. | 1990-06-21 |
| K843186 | ESKA MULTISTAGE ESOPHAGEAL BOUGIE | Dacomed Corp. | 1985-01-18 |
| K842679 | ESOPHAGEAL DILATOR SET | Mill-Rose Laboratory | 1984-10-02 |
| K780471 | GASTRIC LAVAGE KIT | Gaymar Industries, Inc. | 1978-06-02 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| G461EGCT36M0 | Endolumik | Endolumik, Inc. | 2024-08-06 |
| G461EGCT40M0 | Endolumik | Endolumik, Inc. | 2024-08-06 |
| G461EGCT360 | Endolumik | Endolumik, Inc. | 2023-05-15 |
| 14026704719799 | PILLING | TELEFLEX INCORPORATED | 2021-03-11 |
| 14026704719782 | PILLING | TELEFLEX INCORPORATED | 2021-03-11 |
| 14026704719775 | PILLING | TELEFLEX INCORPORATED | 2021-03-11 |
| 14026704719768 | PILLING | TELEFLEX INCORPORATED | 2021-03-11 |
| 14026704719751 | PILLING | TELEFLEX INCORPORATED | 2021-03-11 |
| 14026704719744 | PILLING | TELEFLEX INCORPORATED | 2021-03-11 |
| 14026704719737 | PILLING | TELEFLEX INCORPORATED | 2021-03-11 |
| 14026704719720 | PILLING | TELEFLEX INCORPORATED | 2021-03-11 |
| 14026704719713 | PILLING | TELEFLEX INCORPORATED | 2021-03-11 |
| 14026704719706 | PILLING | TELEFLEX INCORPORATED | 2021-03-11 |
| 14026704719690 | PILLING | TELEFLEX INCORPORATED | 2021-03-11 |
| 14026704719683 | PILLING | TELEFLEX INCORPORATED | 2021-03-11 |
| 14026704719676 | PILLING | TELEFLEX INCORPORATED | 2021-03-11 |
| 14026704719669 | PILLING | TELEFLEX INCORPORATED | 2021-03-11 |
| 14026704719652 | PILLING | TELEFLEX INCORPORATED | 2021-03-11 |
| 14026704719645 | PILLING | TELEFLEX INCORPORATED | 2021-03-11 |
| 14026704719638 | PILLING | TELEFLEX INCORPORATED | 2021-03-11 |
| 14026704719621 | PILLING | TELEFLEX INCORPORATED | 2021-03-11 |
| 14026704719614 | PILLING | TELEFLEX INCORPORATED | 2021-03-11 |
| 14026704719607 | PILLING | TELEFLEX INCORPORATED | 2021-03-11 |
| 14026704719591 | PILLING | TELEFLEX INCORPORATED | 2021-03-11 |
| 14026704719584 | PILLING | TELEFLEX INCORPORATED | 2021-03-11 |
| 14026704719577 | PILLING | TELEFLEX INCORPORATED | 2021-03-11 |
| 14026704719560 | PILLING | TELEFLEX INCORPORATED | 2021-03-11 |
| 14026704719553 | PILLING | TELEFLEX INCORPORATED | 2021-03-11 |
| 14026704719546 | PILLING | TELEFLEX INCORPORATED | 2021-03-11 |
| 14026704719539 | PILLING | TELEFLEX INCORPORATED | 2021-03-11 |