The following data is part of a premarket notification filed by Acclarent, Inc. with the FDA for Acclarent Navwire Sinus Navigation Guidewire.
| Device ID | K161697 |
| 510k Number | K161697 |
| Device Name: | Acclarent NavWire Sinus Navigation Guidewire |
| Classification | Ear, Nose, And Throat Stereotaxic Instrument |
| Applicant | ACCLARENT, INC. 33 TECHNOLOGY DRIVE Irvine, CA 92618 |
| Contact | Anna Hwang |
| Correspondent | Anna Hwang ACCLARENT, INC. 33 TECHNOLOGY DRIVE Irvine, CA 92618 |
| Product Code | PGW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-20 |
| Decision Date | 2016-10-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20705031242903 | K161697 | 000 |
| 20705031237084 | K161697 | 000 |