510(k) K242473

Altis Single Incision Sling System (519650); Aris Transobturator Sling System (519551); Supris Retropubic Sling System (519562) by Coloplast Corp. — Product Code PAH

K242473 is an FDA 510(k) premarket notification submitted by Coloplast Corp. for the device "Altis Single Incision Sling System (519650); Aris Transobturator Sling System (519551); Supris Retropubic Sling System (519562)". The FDA issued a decision of Substantially Equivalent on October 18, 2024. The device falls under product code PAH (Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling), a Class II device regulated under 21 CFR 878.3300. Coloplast Corp. has at least 10 other 510(k) clearances on record.