K002378 is an FDA 510(k) clearance for the MODULAR PORP AND TORP MODEL TBD. This device is classified as a Replacement, Ossicular Prosthesis, Total (Class II - Special Controls, product code ETA).
Submitted by Gyrus Ent LLC (Bartlett, US). The FDA issued a Cleared decision on August 29, 2000, 25 days after receiving the submission on August 4, 2000.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3495.
| 510(k) Number | K002378 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 04, 2000 |
| Decision Date | August 29, 2000 |
| Days to Decision | 25 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | ETA — Replacement, Ossicular Prosthesis, Total |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.3495 |