Cleared Special

K072951 - PARIETENE DUO AND QUADRA POLYPROPYLENE ...

K072951 is the FDA 510(k) clearance for PARIETENE DUO AND QUADRA POLYPROPYLENE ... by Sofradim Production. It is a Class 3 Obstetrics & Gynecology device (product code OTP) cleared through the Special 510(k) pathway after a 62-day FDA review.

K072951 · Sofradim Production · Obstetrics & Gynecology device
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Optimized for regulatory review, auditing and printing
Dec 2007
Decision
62d
Days
Class 3
Risk

K072951 is an FDA 510(k) clearance for the PARIETENE DUO AND QUADRA POLYPROPYLENE MESHES. Classified as Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed (product code OTP), Class III - Premarket Approval.

Submitted by Sofradim Production (Norwalk, US). The FDA issued a Cleared decision on December 19, 2007 after a review of 62 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5980 - 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: High-complexity regulatory submission. High regulatory complexity profile. 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 Sofradim Production devices

Submission Details

510(k) Number K072951 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 2007
Decision Date December 19, 2007
Days to Decision 62 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
98d faster than avg
Panel avg: 160d · This submission: 62d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code OTP Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
Device Class Class 3 - Premarket Approval
CFR Regulation 21 CFR 884.5980
Definition Tissue Reinforcement Of The Fibromuscular Layer Of The Pelvic Floor When Surgical Treatment Is Indicated; Procedures Include Anterior And Posterior Vaginal Wall Prolapse Repair And Vaginal Apical Or Uterine Prolapse Repair Performed Transvaginally
What this classification means

Class III devices typically require Premarket Approval (PMA) with clinical evidence. Clearance through 510(k) for Class III devices is granted only when substantial equivalence to a valid predicate can be established.

Regulatory Peers - OTP Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed

All 23
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