K133439 is an FDA 510(k) clearance for the PILLING ESOPHAGEAL BOUGIES. This device is classified as a Bougie, Esophageal, And Gastrointestinal, Gastro-urology (Class II - Special Controls, product code FAT).
Submitted by Teleflexmedical, Inc. (Durham, US). The FDA issued a Cleared decision on June 16, 2014, 216 days after receiving the submission on November 12, 2013.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5365.
| 510(k) Number | K133439 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 12, 2013 |
| Decision Date | June 16, 2014 |
| Days to Decision | 216 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FAT — Bougie, Esophageal, And Gastrointestinal, Gastro-urology |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5365 |