The following data is part of a premarket notification filed by Acclarent, Inc. with the FDA for Trudi Shaver Blade.
| Device ID | K221037 |
| 510k Number | K221037 |
| Device Name: | TruDi Shaver Blade |
| Classification | Ear, Nose, And Throat Stereotaxic Instrument |
| Applicant | Acclarent, Inc. 31 Technology Drive, Suite 200 Irvine, CA 92618 |
| Contact | Leena Zalavadia |
| Correspondent | Leena Zalavadia Acclarent, Inc. 31 Technology Drive, Suite 200 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 | 2022-04-07 |
| Decision Date | 2022-07-20 |