Cleared Traditional

K121562 - ALTIS SINGLE INCISION CLING SYSTEM

K121562 is the FDA 510(k) clearance for ALTIS SINGLE INCISION CLING SYSTEM by Coloplast A/S. It is a Class 2 Gastroenterology & Urology device (product code PAH) cleared through the Traditional 510(k) pathway after a 160-day FDA review.

K121562 · Coloplast A/S · Gastroenterology & Urology device
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Nov 2012
Decision
160d
Days
Class 2
Risk

K121562 is an FDA 510(k) clearance for the ALTIS SINGLE INCISION CLING SYSTEM. Classified as Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-sling (product code PAH), Class II - Special Controls.

Submitted by Coloplast A/S (Plymouth, US). The FDA issued a Cleared decision on November 5, 2012 after a review of 160 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Coloplast A/S devices

Submission Details

510(k) Number K121562 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 2012
Decision Date November 05, 2012
Days to Decision 160 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
30d slower than avg
Panel avg: 130d · This submission: 160d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Gastroenterology & Urology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT01272284 Completed Interventional Industry-sponsored

The Altis® Single Incision Sling System for Female Stress Urinary Incontinence Study

113
Patients (actual)
17
Sites
Treatment
Purpose
Open label
Masking
Condition studied Stress Urinary Incontinence
Study design Single group
Eligibility Female only · 18 Years+
Principal investigator Ervin Kocjancic, MD
Sponsor Coloplast A/S (industry)
Started 2010-12-01 → Primary completion 2012-07-01 → Completed 2014-01-01
Primary outcome
Percentage of Participants With at Least 50% Reduction in 24-hour Pad Weight From Baseline to 6 Months
Secondary outcome
Percentage of Participants With Negative Cough Stress Test at 6 Months
View full study on ClinicalTrials.gov

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

All 11
Devices cleared under the same product code (PAH) and FDA review panel - the closest regulatory comparables to K121562.
Altis Single Incision Sling System (519650)
K242473 · Coloplast Corp. · Oct 2024
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
AJUST HELICAL ADJUSTABLE SINGLE-INCISION SLING
K123179 · C.R. Bard, Inc. · Nov 2012
MINIARC PRECISE SINGLE-INCISION SLING SYSTEM MODEL: 720181, 720191
K100807 · American Medical Systems, Inc. · Jun 2010
AJUST ADJUSTABLE SINGLE INCISION SLING
K092607 · C.R. Bard, Inc. · Nov 2009