K192397 is an FDA 510(k) clearance for the TruDi Navigation System. This device is classified as a Ear, Nose, And Throat Stereotaxic Instrument (Class II - Special Controls, product code PGW).
Submitted by Biosense Webster (Irvin, US). The FDA issued a Cleared decision on January 30, 2020, 149 days after receiving the submission on September 3, 2019.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 882.4560. 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..
| 510(k) Number | K192397 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 03, 2019 |
| Decision Date | January 30, 2020 |
| Days to Decision | 149 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | PGW - Ear, Nose, And Throat Stereotaxic Instrument |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.4560 |
| Definition | 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. |