510(k) K221098
- Device
- Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software, Electromagnetic Navigation Unit
- Applicant
- Stryker Corporation
- 510(k) number
- K221098
- Product code
- PGW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-07-12
- Date received
- 2022-04-14
- Regulation
- 882.4560
- Classification name
- Ear, Nose, And Throat Stereotaxic Instrument
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Maya Schiel
- Address
- Boetzinger Strasse 41 Freiburg DE D-79111 D-79111
FDA Registration Numbers#
- 3005677016
- 3008203003
- 8043933
- 3018565642
- 3003678543
- 9610617
- 3011874573
- 3010202439
- 3015967359
- 3006345872
- 3010313588
- 1811755
- 2020550
- 3003500271
- 1221485
- 3015462848
- 1928237
- 3009018440
- 3017060084
- 3008837339
- 3010009632
- 3006697241
- 3014342096
- 3005423519
- 1723170
- 3007361893
- 3018094310
- 3010273872
- 3011543740
- 3005172759
- 1824206
- 9610905
- 3015131155
- 1225492
- 3009217531
- 3007738736
- 3016245399
- 8040510
- 3003418325
- 8010177
- 3010707607
- 3008087383
- 2183744
- 3007421149
- 1058084
- 9680721
Source Documents#
Other 510(k) Records For Product Code PGW#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253395 | Stealth AXiS™ ENT clinical application | Medtronic Navigation, Inc. | 2026-03-16 |
| K243053 | Navient Image Guided Navigation System (ENT) (955-NC-NC) | Claronav | 2025-06-20 |
| K231862 | TruDi® Navigation System V3 (FG-2000-00) | Acclarent, Inc. | 2023-07-21 |
| K223734 | ENT EM | Brainlab AG | 2023-04-27 |
| K221037 | TruDi Shaver Blade | Acclarent, Inc. | 2022-07-20 |
| K211291 | Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4D | Fiagon GmbH | 2021-07-19 |
| K202609 | Instrument Clamps Electromagnetic | Stryker Corporation | 2020-10-09 |
| K201174 | TruDi Curette | Acclarent, Inc. | 2020-08-12 |
| K200723 | StealthStation FlexENT (9736242), StealthStation S8 ENT Software (9735762) | Medtronic Navigation, Inc. | 2020-06-26 |
| K193453 | TruDi Probe | Acclarent, Inc. | 2020-03-23 |
| K200041 | FlexPointer 1.5 Single Use, FlexTube 3 Single Use | Fiagon GmbH | 2020-03-10 |
| K193118 | TGS Guidewire and updated Scopis Software | Stryker Ent | 2020-02-21 |
| K193502 | TGS Universal Headrest with Mounting Arm | Stryker Ent | 2020-02-14 |
| K192397 | TruDi Navigation System | Biosense Webster | 2020-01-30 |
| K190532 | TruDi NAV Wire | Acclarent, Inc. | 2019-05-03 |