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) Official FDA 510(k) Summary (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.

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
134d faster than avg
Panel avg: 161d · 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 22
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
K140116 · RESTORELLE Y CONTOUR MESH
Download PDF FDA Summary Coloplast A/S