K043375 is an FDA 510(k) clearance for the FISCH TITANIUM MIDDLE EAR PROSTHESES. This device is classified as a Replacement, Ossicular Prosthesis, Total (Class II - Special Controls, product code ETA).
Submitted by Karl Storz Endoscopy (Culver City, US). The FDA issued a Cleared decision on January 24, 2005, 47 days after receiving the submission on December 8, 2004.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3495.
| 510(k) Number | K043375 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 08, 2004 |
| Decision Date | January 24, 2005 |
| Days to Decision | 47 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 |