Cleared Special

K053361 - MODIFICATION TO: MINIMESH POLYPROPYLENE...

K053361 is an FDA 510(k) clearance for MODIFICATION TO: MINIMESH POLYPROPYLENE..., manufactured by Mpathy Medical Devices, Ltd.. The device is a Class 2 Obstetrics & Gynecology device with product code OTO cleared through the Special 510(k) pathway after a 66-day FDA review.

K053361 · Mpathy Medical Devices, Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2006
Decision
66d
Days
Class 2
Risk

K053361 is an FDA 510(k) clearance for the MODIFICATION TO: MINIMESH POLYPROPYLENE MESH. Classified as Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed (product code OTO), Class II - Special Controls.

Submitted by Mpathy Medical Devices, Ltd. (Farfield, US). The FDA issued a Cleared decision on February 6, 2006 after a review of 66 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 Mpathy Medical Devices, Ltd. devices

FDA 510(k) Submission Details - K053361

510(k) Number K053361 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 2005
Decision Date February 06, 2006
Days to Decision 66 days
Submission Type Special
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 160d · This submission: 66d
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 13
Devices cleared under the same product code (OTO) and FDA review panel - the closest regulatory comparables to K053361.
RESTORELLE POLYPROPYLENE Y MESH
K112322 · Coloplast A/S · May 2012
ALYTE Y-MESH GRAFT
K101722 · C.R. Bard, Inc. · Apr 2011
BARD SACROCOLPOPEXY GRAFT
K090739 · C.R. Bard, Inc. · Nov 2009
AMS PELVIC FLOOR REPAIR SYSTEM
K051485 · American Medical Systems, Inc. · Aug 2005
AMS SACRAL COLPOPEXY SLING, MODEL 72403501
K010931 · American Medical Systems, Inc. · Apr 2001