Cleared Traditional

K242473 - Altis Single Incision Sling System (519650)

Also marketed or referenced as:
Aris Transobturator Sling System (519551) Supris Retropubic Sling System (519562)

K242473 is an FDA 510(k) clearance for Altis Single Incision Sling System (519650), manufactured by Coloplast Corp.. The device is a Class 2 Gastroenterology & Urology device with product code PAH cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K242473 · Coloplast Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K242473

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
72d faster than avg
Panel avg: 131d · This submission: 59d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PAH Device Classification - Class 2, Special Controls

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.

Regulatory Peers - PAH Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-sling

All 14
Devices cleared under the same product code (PAH) and FDA review panel - the closest regulatory comparables to K242473.
Altis Single Incision Sling System
K221874 · Coloplast A/S · Feb 2023
Desara One Single Incision Sling System, 1 Pack
K191416 · Caldera Medical, Inc. · Feb 2020
ALTIS SINGLE INCISION CLING SYSTEM
K121562 · Coloplast A/S · Nov 2012
AJUST HELICAL ADJUSTABLE SINGLE-INCISION SLING
K123179 · C.R. Bard, Inc. · Nov 2012
MINIARC PRO SINGLE-INCISION SLING SYSTEM
K121641 · American Medical Systems · Sep 2012
OPHIRA MINI SLING SYSTEM
K110420 · Promedon S.A · May 2012