K113522 is an FDA 510(k) clearance for the PATHASSIST LIGHT 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 January 27, 2012, 59 days after receiving the submission on November 29, 2011.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4420.
| 510(k) Number | K113522 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 29, 2011 |
| Decision Date | January 27, 2012 |
| Days to Decision | 59 days |
| Submission Type | Special |
| 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 |