Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software, Electromagnetic Navigation Unit
FDA 510(k) K221098 · Stryker Corporation
Submission
- Device name
- Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software, Electromagnetic Navigation Unit
- Applicant
- Stryker Corporation
Freiburg, DE - Received
- April 14, 2022
- Decision date
- July 12, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PGW – Ear, Nose, And Throat Stereotaxic Instrument
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.4560
- Specialty
- Neurology
Intended as an aid for precisely locating a surgical instrument within anatomical structures in either open or percutaneous procedures for any medical condition in which a reference to a rigid anatomical structure in the field of ENT surgery can be identified relative to a CT- or MR-based model or digitized landmarks of the anatomy.
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| K243053 | Navient Image Guided Navigation System (ENT) (955-NC-NC)PGW · Traditional | Claronav | 06/20/2025SE |
| K231862 | TruDi® Navigation System V3 (FG-2000-00)PGW · Special | Acclarent, Inc. | 07/21/2023SE |
| K223734 | ENT EmPGW · Traditional | Brainlab AG | 04/27/2023SE |
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| K211291 | Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4DPGW · Traditional | Fiagon GmbH | 07/19/2021SE |
| K202609 | Instrument Clamps ElectromagneticPGW · Special | Stryker Corporation | 10/09/2020SE |
| K201174 | TruDi CurettePGW · Traditional | Acclarent, Inc. | 08/12/2020SE |
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Questions and answers
When was Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software, Electromagnetic Navigation Unit cleared by the FDA?
Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software, Electromagnetic Navigation Unit (K221098) received a 510(k) decision of Substantially Equivalent on July 12, 2022, 89 days after the submission was received.
What is the product code of K221098?
The FDA product code is PGW – Ear, Nose, And Throat Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.