K231862 is an FDA 510(k) clearance for the TruDi® Navigation System V3 (FG-2000-00). This device is classified as a Ear, Nose, And Throat Stereotaxic Instrument (Class II - Special Controls, product code PGW).
Submitted by Acclarent, Inc. (Irvine, US). The FDA issued a Cleared decision on July 21, 2023, 28 days after receiving the submission on June 23, 2023.
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 | K231862 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 23, 2023 |
| Decision Date | July 21, 2023 |
| Days to Decision | 28 days |
| Submission Type | Special |
| 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. |