510(k) K192397
K192397 is an FDA 510(k) premarket notification submitted by Biosense Webster for the device "TruDi Navigation System". The FDA issued a decision of Substantially Equivalent on January 30, 2020. The device falls under product code PGW (Ear, Nose, And Throat Stereotaxic Instrument), a Class II device regulated under 21 CFR 882.4560. Biosense Webster has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 30, 2020
- Date Received
- September 3, 2019
- 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.