K242960
- 510(k) number
- K242960
- Device name
- AdVance XP Male Sling System (720163-03)
- Applicant
- Boston Scientific Corporation MA · US
- Product code
- OTM — Mesh, Surgical, For Stress Urinary Incontinence, Mal
- Decision date
- 2024-11-15
- Date received
- 2024-09-25
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K242960.pdf
Official FDA record: K242960
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.