Cleared Special

K140116 - RESTORELLE Y CONTOUR MESH

K140116 is an FDA 510(k) clearance for RESTORELLE Y CONTOUR MESH, manufactured by Coloplast A/S. The device is a Class 2 Obstetrics & Gynecology device with product code OTO cleared through the Special 510(k) pathway after a 27-day FDA review.

K140116 · Coloplast A/S · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2014
Decision
27d
Days
Class 2
Risk

K140116 is an FDA 510(k) clearance for the RESTORELLE Y CONTOUR MESH. Classified as Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed (product code OTO), Class II - Special Controls.

Submitted by Coloplast A/S (Plymouth, US). The FDA issued a Cleared decision on February 12, 2014 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 878.3300 - the FDA obstetrics and gynecology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Coloplast A/S devices

FDA 510(k) Submission Details - K140116

510(k) Number K140116 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 2014
Decision Date February 12, 2014
Days to Decision 27 days
Submission Type Special
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
133d faster than avg
Panel avg: 160d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

OTO Device Classification - Class 2, Special Controls

Product Code OTO Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3300
Definition Bridging Material To Attach The Vaginal Apex To The Anterior Longitudinal Ligament Of The Sacrum; Procedures Include Abdominal Sacrocolpopexy And Laparoscopic Sacrocolpopexy.
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 Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - OTO Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed

All 16
Devices cleared under the same product code (OTO) and FDA review panel - the closest regulatory comparables to K140116.
Polyform Synthetic Mesh
K171271 · Boston Scientific Corporation · Dec 2017
Vertessa Lite
K150016 · Caldera Medical, Inc. · Apr 2015
Vertessa Lite Y-Mesh
K150023 · Caldera Medical, Inc. · Apr 2015
RESTORELLE M, RESTORELLE XL
K132061 · Coloplast Corp. · Aug 2013
VERTESSA LITE 10 X20CM, VERTESSA LITE 11 X 30CM, VERTESSA LITE Y-MESH
K123028 · Caldera Medical, Inc. · Apr 2013
RESTORELLE Y CONTOUR
K123914 · Coloplast A/S · Mar 2013