FDA Product Code
FDA Product Code FAT — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5365
510(k) Clearances — 8 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K133439 | PILLING ESOPHAGEAL BOUGIES | Teleflexmedical, Inc. | 2014-06-16 | Traditional | PDF ↗ |
| K983220 | STRYKER INFRAVISION ESOPHAGEAL KIT | Stryker Endoscopy | 1999-06-04 | Traditional | PDF ↗ |
| K972119 | MALONEY BOUGE (1210-XX)/HURST BOUGIE (1212-XX) | Medovations, Inc. | 1998-02-02 | Traditional | PDF ↗ |
| K960173 | INFRA VISION BOUGIE KIT, INFRA VISION ESOPHAGEAL KIT | Gabriel Medical, Inc. | 1996-06-27 | Traditional | PDF ↗ |
| K901425 | PYLORIC BALLOON DILATOR | Telemed Systems, Inc. | 1990-06-21 | Traditional | PDF ↗ |
| K843186 | ESKA MULTISTAGE ESOPHAGEAL BOUGIE | Dacomed Corp. | 1985-01-18 | Traditional | PDF ↗ |
| K842679 | ESOPHAGEAL DILATOR SET | Mill-Rose Laboratory | 1984-10-02 | Traditional | PDF ↗ |
| K780471 | GASTRIC LAVAGE KIT | Gaymar Industries, Inc. | 1978-06-02 | Traditional | PDF ↗ |
Product code FAT · Class II · Gastroenterology, Urology. Data: openFDA.