510(k) K221098
K221098 is an FDA 510(k) premarket notification submitted by Stryker Corporation for the device "Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software, Electromagnetic Navigation Unit". The FDA issued a decision of Substantially Equivalent on July 12, 2022. The device falls under product code PGW (Ear, Nose, And Throat Stereotaxic Instrument), a Class II device regulated under 21 CFR 882.4560. Stryker Corporation has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 12, 2022
- Date Received
- April 14, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ear, Nose, And Throat Stereotaxic Instrument
- Device Class
- Class II
- Regulation Number
- 882.4560
- Review Panel
- EN
- Submission Type
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.