510(k) K160479
K160479 is an FDA 510(k) premarket notification submitted by Fiagon GmbH for the device "PointerShell Universal, PointerShell LS". The FDA issued a decision of Substantially Equivalent on March 23, 2016. The device falls under product code PGW (Ear, Nose, And Throat Stereotaxic Instrument), a Class II device regulated under 21 CFR 882.4560. Fiagon GmbH has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 23, 2016
- Date Received
- February 22, 2016
- Clearance Type
- Special
- 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
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.