510(k) K210478
K210478 is an FDA 510(k) premarket notification submitted by Iconocare Health for the device "8mm Monopolar Curved Scissors". The FDA issued a decision of Substantially Equivalent on Sep 30, 2022. The device falls under product code QSM (System, Surgical, Computer Controlled Instrument, Remanufactured), a Class II device regulated under 21 CFR 876.1500. Iconocare Health has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 30, 2022
- Date Received
- Feb 19, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Surgical, Computer Controlled Instrument, Remanufactured
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- SU
- Submission Type
As intended with the originally cleared instrument.