K091135 is an FDA 510(k) clearance for the RUTTER SUPRA STOMAL STENTS. This device is classified as a Prosthesis, Larynx (stents And Keels) (Class II - Special Controls, product code FWN).
Submitted by Boston Medical Products, Inc. (Westborough, US). The FDA issued a Cleared decision on September 14, 2009, 147 days after receiving the submission on April 20, 2009.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3620.
| 510(k) Number | K091135 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 20, 2009 |
| Decision Date | September 14, 2009 |
| Days to Decision | 147 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Statement |
| Product Code | FWN — Prosthesis, Larynx (stents And Keels) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.3620 |