K221037 is an FDA 510(k) clearance for the TruDi Shaver Blade. 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 20, 2022, 104 days after receiving the submission on April 7, 2022.
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 | K221037 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 07, 2022 |
| Decision Date | July 20, 2022 |
| Days to Decision | 104 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. |