K242473
- 510(k) number
- K242473
- Device name
- Altis Single Incision Sling System (519650); Aris Transobturator Sling System (519551); Supris Retropubic Sling System (519562)
- Applicant
- Coloplast Corp. MN · US
- Product code
- PAH — Mesh, Surgical, Synthetic, Urogynecologic, For Stres
- Decision date
- 2024-10-18
- Date received
- 2024-08-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K242473.pdf
Official FDA record: K242473
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.