510(k) K161491
K161491 is an FDA 510(k) premarket notification submitted by Scopis GmbH for the device "Scopis Hybrid Navigation System EM". The FDA issued a decision of Substantially Equivalent on Feb 9, 2017. The device falls under product code PGW (Ear, Nose, And Throat Stereotaxic Instrument), a Class II device regulated under 21 CFR 882.4560. Scopis GmbH has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 9, 2017
- Date Received
- Jun 1, 2016
- 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
- 510(k)
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.