The following data is part of a premarket notification filed by Acclarent, Inc. with the FDA for Trudi Curette.
| Device ID | K201174 |
| 510k Number | K201174 |
| Device Name: | TruDi Curette |
| 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 | 2020-05-01 |
| Decision Date | 2020-08-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20705031465432 | K201174 | 000 |
| 20705031465425 | K201174 | 000 |