Cleared Traditional

MINIMESH POLYPROPYLENE MESH (K041632) - FDA 510(k) Clearance

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K041632 · Mpathy Medical Devices, Ltd. · Obstetrics & Gynecology device
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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

Submission Details

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.

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 22
Devices cleared under the same product code (OTO) and FDA review panel - the closest regulatory comparables to K041632.
Polyform Synthetic Mesh
K171271 · Boston Scientific Corporation · Dec 2017
UPSYLON Y MESH
K122794 · Boston Scientific Corp · Dec 2012
ALYTE Y-MESH GRAFT
K101722 · C.R. Bard, Inc. · Apr 2011
BARD SACROCOLPOPEXY GRAFT
K090739 · C.R. Bard, Inc. · Nov 2009