FDA 510(k) K242473, Altis Single Incision Sling System (519650); Aris Transobturator Sling System (519551); Supris Retropubic Sling System (519562), by Coloplast Corp.
FDA 510(k) K242473, Altis Single Incision Sling System (519650); Aris Transobturator Sling System (519551); Supris Retropubic Sling System (519562), by Coloplast Corp.
Device Classification Name: Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling
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.
Regulation Number: 878.3300
Classification Product Code: PAH
Date Received: 08/20/2024
Decision Date: 10/18/2024
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
510k Review Panel: Gastroenterology/Urology
Total number of pages: 1,593
Fully redacted pages: 1,184
Content pages: 409
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