510(k) K221818
K221818 is an FDA 510(k) premarket notification submitted by Morpheus AG for the device "Rebellion; Phantom Multi-Bite Kerrison Rongeur". The FDA issued a decision of Substantially Equivalent on October 7, 2022. The device falls under product code HAE (Rongeur, Manual), a Class II device regulated under 21 CFR 882.4840. Morpheus AG has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 7, 2022
- Date Received
- June 23, 2022
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Rongeur, Manual
- Device Class
- Class II
- Regulation Number
- 882.4840
- Review Panel
- NE
- Submission Type