K102003 is an FDA 510(k) clearance for the XPRESS BALLOON DEVICE. 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 October 22, 2010, 99 days after receiving the submission on July 15, 2010.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4420.
| 510(k) Number | K102003 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 15, 2010 |
| Decision Date | October 22, 2010 |
| Days to Decision | 99 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 |