TruDi Shaver Blade
510(k) K221037
TruDi Shaver Blade is a medical device (FDA Class II; FDA product code PGW, Ear, Nose, And Throat Stereotaxic Instrument) made by Acclarent, Inc., cleared under FDA 510(k) K221037 on 20 Jul 2022, active as of 11 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK221037 | Date20 Jul 2022 | StatusActive |
Official records
- FDA 510(k) database K221037
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- PGW
- Device class
- Class II
- Regulation
- 21 CFR Part 882.4560
- Advisory committee
- Neurology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K221037
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| TruDi Shaver Blade TSB3STR | TSB3STR / TSB3STR | 10705031469242 | — | On the market |
| TruDi Shaver Blade TSB3STRZ | TSB3STRZ / TSB3STRZ | 20705031469256 | — | On the market |
| TruDi Shaver Blade TSB415 | TSB415 / TSB415 | 10705031469297 | — | On the market |
| TruDi Shaver Blade TSB415Z | TSB415Z / TSB415Z | 20705031469287 | — | On the market |
| TruDi Shaver Blade TSB440 | TSB440 / TSB440 | 10705031469273 | — | On the market |
| TruDi Shaver Blade TSB440Z | TSB440Z / TSB440Z | 20705031469263 | — | On the market |
| TruDi Shaver Blade TSB460 | TSB460 / TSB460 | 10705031469211 | — | On the market |
| TruDi Shaver Blade TSB460Z | TSB460Z / TSB460Z | 20705031469300 | — | On the market |
| TruDi Shaver Blade TSB4STR | TSB4STR / TSB4STR | 10705031469235 | — | On the market |
| TruDi Shaver Blade TSB4STRZ | TSB4STRZ / TSB4STRZ | 20705031469225 | — | On the market |
Similar devices
Other devices filed under FDA product code PGW (Ear, Nose, And Throat Stereotaxic Instrument).
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- Cube 4D Navigation System, VirtuEye Pro by Fiagon GmbH
- KARL STORZ NAV1 Electromagnetic Navigation System by Karl Storz Endoscopy-America, Inc.
- TGS Navigation 8000-010-003 by Stryker Leibinger