K120735 is an FDA 510(k) clearance for the PATHASSIT 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 April 2, 2012, 24 days after receiving the submission on March 9, 2012.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4420.
| 510(k) Number | K120735 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 09, 2012 |
| Decision Date | April 02, 2012 |
| Days to Decision | 24 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 |