K250645
- 510(k) number
- K250645
- Device name
- SleeveLUX 24 Anoscope/Proctoscope (P2001); SleeveLUX 16 Anoscope/Proctoscope (P2002)
- Applicant
- Haemoband Surgical, Ltd. GB
- Product code
- FER — Anoscope And Accessories
- Decision date
- 2025-10-09
- Date received
- 2025-03-04
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K250645.pdf
Official FDA record: K250645
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.