510(k) K250399
K250399 is an FDA 510(k) premarket notification submitted by Rebotix for the device "Remanufactured EndoWrist Cadiere Forceps (420049)". The FDA issued a decision of Substantially Equivalent on Aug 19, 2025. The device falls under product code QSM (System, Surgical, Computer Controlled Instrument, Remanufactured), a Class II device regulated under 21 CFR 876.1500. Rebotix has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 19, 2025
- Date Received
- Feb 12, 2025
- 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.