K081542 is an FDA 510(k) clearance for the MODIFICATION TO ENTELLUS MEDICAL RS-SERIES SYSTEM. This device is classified as a Instrument, Ent Manual Surgical (Class I - General Controls, product code LRC).
Submitted by Entellus Medical, Inc. (Plymouth, US). The FDA issued a Cleared decision on June 27, 2008, 25 days after receiving the submission on June 2, 2008.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4420.
| 510(k) Number | K081542 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 02, 2008 |
| Decision Date | June 27, 2008 |
| Days to Decision | 25 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 |