K972119 is an FDA 510(k) clearance for the MALONEY BOUGE (1210-XX)/HURST BOUGIE (1212-XX). This device is classified as a Bougie, Esophageal, And Gastrointestinal, Gastro-urology (Class II - Special Controls, product code FAT).
Submitted by Medovations, Inc. (Germantown, US). The FDA issued a Cleared decision on February 2, 1998, 242 days after receiving the submission on June 5, 1997.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5365.
| 510(k) Number | K972119 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 05, 1997 |
| Decision Date | February 02, 1998 |
| Days to Decision | 242 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | FAT — Bougie, Esophageal, And Gastrointestinal, Gastro-urology |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5365 |