K260183
- 510(k) number
- K260183
- Device name
- MediBot Needle Driver Uno
- Applicant
- Parallel Robotics, LLC MI · US
- Product code
- GCJ — Laparoscope, General & Plastic Surgery
- Decision date
- 2026-05-24
- Date received
- 2026-01-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K260183.pdf
Official FDA record: K260183
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.