K260089
- 510(k) number
- K260089
- Device name
- TL-10 Laparoscopic Scope Cleaner
- Applicant
- Scopix , Ltd. IL
- Product code
- GCJ — Laparoscope, General & Plastic Surgery
- Decision date
- 2026-04-08
- Date received
- 2026-01-12
- 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: K260089.pdf
Official FDA record: K260089
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.