510(k) K150718
K150718 is an FDA 510(k) premarket notification submitted by Agency For Medical Innovations GmbH for the device "Wi-3 HAL-RAR System". The FDA issued a decision of Substantially Equivalent on June 12, 2015. The device falls under product code FHN (Ligator, Hemorrhoidal), a Class II device regulated under 21 CFR 876.4400. Agency For Medical Innovations GmbH has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 12, 2015
- Date Received
- March 19, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ligator, Hemorrhoidal
- Device Class
- Class II
- Regulation Number
- 876.4400
- Review Panel
- GU
- Submission Type