Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software, Electromagnetic Navigation Unit
FDA 510(k) clearance K221098 · decided 2022-07-12
Clearance details
- K-number
- K221098
- Device name
- Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software, Electromagnetic Navigation Unit
- Applicant
- Stryker Corporation
- Decision
- Substantially Equivalent
- Date received
- 2022-04-14
- Decision date
- 2022-07-12
- Days to decision
- 89 days
- Clearance type
- Traditional
- Product code
- PGW
- Device class
- 2
- Regulation number
- 882.4560
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Freiburg, DE
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Stryker Corporation
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Cube 4D Navigation System, VirtuEye Pro (K261540) | Fiagon GmbH | 2026-06-02 |
| Stealth AXiS™ ENT clinical application (K253395) | Medtronic Navigation, Inc. | 2026-03-16 |
| Navient Image Guided Navigation System (ENT) (955-NC-NC) (K243053) | Claronav | 2025-06-20 |
| TruDi® Navigation System V3 (FG-2000-00) (K231862) | Acclarent, Inc. | 2023-07-21 |
| ENT EM (K223734) | Brainlab AG | 2023-04-27 |
| TruDi Shaver Blade (K221037) | Acclarent, Inc. | 2022-07-20 |
| Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4D (K211291) | Fiagon GmbH | 2021-07-19 |
| Instrument Clamps Electromagnetic (K202609) | Stryker Corporation | 2020-10-09 |
| TruDi Curette (K201174) | Acclarent, Inc. | 2020-08-12 |
| StealthStation FlexENT (9736242), StealthStation S8 ENT Software (9735762) (K200723) | Medtronic Navigation, Inc. | 2020-06-26 |
| TruDi Probe (K193453) | Acclarent, Inc. | 2020-03-23 |
| FlexPointer 1.5 Single Use, FlexTube 3 Single Use (K200041) | Fiagon GmbH | 2020-03-10 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| 8000-021-002, Scopis ENT Software with TGS with Sofware Version: NOVA 3.6.0 RC16. Scopis i recall (Z-1885-2024) | Stryker Leibinger GmbH & Co. KG | 2024-05-23 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| BRAUN-CUTTER TRAPEZO-METACARPAL PROSTHESIS (P960053/S005) | Stryker Corporation | 2016-08-09 |
| SBI BRAUN-CUTTER TRAPEZ-METACARPAL PROSTHESIS (P960053/S004) | Stryker Corporation | 2007-09-28 |
| BRAUN-CUTTER TRAPEZO-METACARPAL PROSTHESIS (P960053/S003) | Stryker Corporation | 2002-12-31 |
| TOTAL TRAPEZIO METACARPAL PROSTHESIS (P960053/S002) | Stryker Corporation | 1998-06-04 |
| TOTAL TRAPEZIO METACARPAL PROSTHESIS (P960053/S001) | Stryker Corporation | 1998-06-04 |
| BRAUN-CUTTER TRAPEZO-METACARPAL PROSTHESIS (P960053) | Stryker Corporation | 1997-06-19 |