Cleared Traditional

K041632 - MINIMESH POLYPROPYLENE MESH

K041632 is an FDA 510(k) clearance for MINIMESH POLYPROPYLENE MESH, manufactured by Mpathy Medical Devices, Ltd.. The device is a Class 2 Obstetrics & Gynecology device with product code OTO cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K041632 · Mpathy Medical Devices, Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2004
Decision
154d
Days
Class 2
Risk

K041632 is an FDA 510(k) clearance for the 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 November 17, 2004 after a review of 154 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 878.3300 - the FDA obstetrics and gynecology 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 Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Mpathy Medical Devices, Ltd. devices

FDA 510(k) Submission Details - K041632

510(k) Number K041632 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 2004
Decision Date November 17, 2004
Days to Decision 154 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
6d faster than avg
Panel avg: 160d · This submission: 154d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K041632.
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