The following data is part of a premarket notification filed by Acclarent, Inc. with the FDA for Trudi Probe.
| Device ID | K193453 |
| 510k Number | K193453 |
| Device Name: | TruDi Probe |
| Classification | Ear, Nose, And Throat Stereotaxic Instrument |
| Applicant | Acclarent, Inc. 31 Technology Drive Irvine, CA 92618 |
| Contact | Leena Sorathia |
| Correspondent | Leena Sorathia Acclarent, Inc. 31 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 | 2019-12-13 |
| Decision Date | 2020-03-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20705031464220 | K193453 | 000 |
| 20705031464213 | K193453 | 000 |
| 20705031464206 | K193453 | 000 |
| 20705031464190 | K193453 | 000 |