K050340 is an FDA 510(k) clearance for the MICROMEDICS SPHENOID SINUS STENT. This device is classified as a Cannula, Sinus (Class I - General Controls, product code KAM).
Submitted by Micromedics, Inc. (St. Paul, US). The FDA issued a Cleared decision on April 27, 2005, 75 days after receiving the submission on February 11, 2005.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K050340 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 11, 2005 |
| Decision Date | April 27, 2005 |
| Days to Decision | 75 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | KAM — Cannula, Sinus |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |