510(k) K161507
K161507 is an FDA 510(k) premarket notification submitted by Cianna Medical, Inc. for the device "Cianna Medical SAVI Scout Reflector and SAVI Scout System". The FDA issued a decision of Substantially Equivalent on July 29, 2016. The device falls under product code PDW (Internal Tissue Marker), a Class II device regulated under 21 CFR 878.4670. Cianna Medical, Inc. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 29, 2016
- Date Received
- June 1, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Internal Tissue Marker
- Device Class
- Class II
- Regulation Number
- 878.4670
- Review Panel
- SU
- Submission Type
An internal tissue marker is a prescription use device that is intended for use prior to or during general surgical procedures to demarcate selected sites on internal tissues.