Cleared Traditional

Altis Single Incision Sling System (519650); Aris Transobturator Sling System (519551); Supris Retropubic Sling System (519562)

K242473 · Coloplast Corp. · Gastroenterology & Urology

Oct 2024

Decision

59d

Days

Class 2

Risk

About This 510(k) Submission

K242473 is an FDA 510(k) clearance for the Altis Single Incision Sling System (519650); Aris Transobturator Sling System (519551); Supris Retropubic Sling System (519562), a Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-sling (Class II — Special Controls, product code PAH), submitted by Coloplast Corp. (Plymouth, US). The FDA issued a Cleared decision on October 18, 2024, 59 days after receiving the submission on August 20, 2024. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 878.3300.

Submission Details

510(k) Number	K242473 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 20, 2024
Decision Date	October 18, 2024
Days to Decision	59 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF

Device Classification

Product Code	PAH — Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-sling
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 878.3300
Definition	Transvaginal Surgical Repair Of Female Stress Urinary Incontinence (sui) Due To Intrinsic Sphincter Deficiency (isd) And/or Urethral Hypermobility.