K250387 is an FDA 510(k) clearance for the Remanufactured EndoWrist Long Tip Forceps (420048). This device is classified as a System, Surgical, Computer Controlled Instrument, Remanufactured (Class II - Special Controls, product code QSM).
Submitted by Rebotix (St. Petersburg, US). The FDA issued a Cleared decision on August 19, 2025, 189 days after receiving the submission on February 11, 2025.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 876.1500. As Intended With The Originally Cleared Instrument..
| 510(k) Number | K250387 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 11, 2025 |
| Decision Date | August 19, 2025 |
| Days to Decision | 189 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | QSM - System, Surgical, Computer Controlled Instrument, Remanufactured |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |
| Definition | As Intended With The Originally Cleared Instrument. |