K110158 is an FDA 510(k) clearance for the ILLUMINATING SINUS SEEKER. This device is classified as a Instrument, Ent Manual Surgical (Class I - General Controls, product code LRC).
Submitted by Entellus Medical, Inc. (Maple Grove, US). The FDA issued a Cleared decision on June 7, 2011, 139 days after receiving the submission on January 19, 2011.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4420.
| 510(k) Number | K110158 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 19, 2011 |
| Decision Date | June 07, 2011 |
| Days to Decision | 139 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 |