Cleared Special

K132061 - RESTORELLE M

K132061 is the FDA 510(k) clearance for RESTORELLE M by Coloplast Corp.. It is a Class 2 Obstetrics & Gynecology device (product code OTO) cleared through the Special 510(k) pathway after a 30-day FDA review.

K132061 · Coloplast Corp. · Obstetrics & Gynecology device
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Aug 2013
Decision
30d
Days
Class 2
Risk

K132061 is an FDA 510(k) clearance for the RESTORELLE M, RESTORELLE XL. Classified as Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed (product code OTO), Class II - Special Controls.

Submitted by Coloplast Corp. (Minneapolis, US). The FDA issued a Cleared decision on August 2, 2013 after a review of 30 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 Corp. devices

Submission Details

510(k) Number K132061 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 2013
Decision Date August 02, 2013
Days to Decision 30 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
130d faster than avg
Panel avg: 160d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 12
Devices cleared under the same product code (OTO) and FDA review panel - the closest regulatory comparables to K132061.
Polyform Synthetic Mesh
K171271 · Boston Scientific Corporation · Dec 2017
RESTORELLE Y CONTOUR MESH
K140116 · Coloplast A/S · Feb 2014
RESTORELLE Y CONTOUR
K123914 · Coloplast A/S · Mar 2013
UPSYLON Y MESH
K122794 · Boston Scientific Corp · Dec 2012
NOVASILK MESH QTY 1 MODEL 93-6014, NOVASILK MESH QTY 3 MODEL 93-6015
K122968 · Coloplast Corp. · Dec 2012
RESTORELLE L
K122440 · Coloplast Corp. · Nov 2012