K150172 is an FDA 510(k) clearance for the ACCLARENT SE Inflation Device. 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 April 7, 2015, 71 days after receiving the submission on January 26, 2015.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4420.
| 510(k) Number | K150172 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 26, 2015 |
| Decision Date | April 07, 2015 |
| Days to Decision | 71 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 |