Cleared Traditional

K242473 - Altis Single Incision Sling System (519650) (FDA 510(k) Clearance)

Also includes:
Aris Transobturator Sling System (519551) Supris Retropubic Sling System (519562)

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K242473 · Coloplast Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
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Oct 2024
Decision
59d
Days
Class 2
Risk

K242473 is an FDA 510(k) clearance for the Altis Single Incision Sling System (519650). Classified as Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-sling (product code PAH), Class II - Special Controls.

Submitted by Coloplast Corp. (Plymouth, US). The FDA issued a Cleared decision on October 18, 2024 after a review of 59 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 878.3300 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Coloplast Corp. devices

Submission Details

510(k) Number K242473 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 130d · This submission: 59d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PAH Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-sling
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.