KARL STORZ NAV1 Electromagnetic Navigation System
FDA 510(k) clearance K161555 · decided 2016-10-21
Clearance details
- K-number
- K161555
- Device name
- KARL STORZ NAV1 Electromagnetic Navigation System
- Applicant
- Karl Storz Endoscopy America, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2016-06-06
- Decision date
- 2016-10-21
- Days to decision
- 137 days
- Clearance type
- Traditional
- Product code
- PGW
- Device class
- 2
- Regulation number
- 882.4560
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- El Segundo, CA, US
- Third-party review
- No
- Expedited review
- No
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| TruDi Shaver Blade (K221037) | Acclarent, Inc. | 2022-07-20 |
| Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software, Electromagnetic Navigation Unit (K221098) | Stryker Corporation | 2022-07-12 |
| 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 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Photodynamic Diagnostic D-Light C System (P050027/S034) | KARL STORZ Endoscopy-America, Inc. | 2025-10-01 |
| KARL STORZ Photodynamic Diagnostic D-Light C (PDD) System (P050027/S033) | KARL STORZ Endoscopy-America, Inc. | 2025-05-02 |
| KARL STORZ Photodynamic Diagnostic D-Light C (PDD) System (P050027/S032) | KARL STORZ Endoscopy-America, Inc. | 2024-09-27 |
| KARL STORZ D-Light C PDD System (P050027/S031) | KARL STORZ Endoscopy-America, Inc. | 2023-05-05 |
| KARL STORZ D-Light C PDD System (P050027/S030) | KARL STORZ Endoscopy-America, Inc. | 2022-03-17 |
| KARL STORZ D-Light C PDD System (P050027/S028) | KARL STORZ Endoscopy-America, Inc. | 2022-02-04 |
| KARL STORZ D-Light C PDD System (P050027/S029) | KARL STORZ Endoscopy-America, Inc. | 2021-10-13 |
| D-Light C PDD System (P050027/S027) | KARL STORZ Endoscopy-America, Inc. | 2021-01-08 |