K111875 is an FDA 510(k) clearance for the RELIEVA SPIN SINUS DILATION SYSTEM. This device is classified as a Instrument, Ent Manual Surgical (Class I - General Controls, product code LRC).
Submitted by Acclarent, Inc. (Rmenlo Park, US). The FDA issued a Cleared decision on October 11, 2011, 102 days after receiving the submission on July 1, 2011.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4420.
| 510(k) Number | K111875 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 01, 2011 |
| Decision Date | October 11, 2011 |
| Days to Decision | 102 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | LRC — Instrument, Ent Manual Surgical |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 874.4420 |