K170018 is an FDA 510(k) clearance for the StealthStationTM S8 ENT Software. This device is classified as a Ear, Nose, And Throat Stereotaxic Instrument (Class II - Special Controls, product code PGW).
Submitted by Medtronic Navigation, Inc. (Louisville, US). The FDA issued a Cleared decision on May 19, 2017, 136 days after receiving the submission on January 3, 2017.
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 | K170018 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 03, 2017 |
| Decision Date | May 19, 2017 |
| Days to Decision | 136 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. |