Cleared Traditional

K130006 - BIODESIGN SURGISIS ANTERIOR POSTERIOR PELVIC FLOOR GRAFTS (FDA 510(k) Clearance)

Class III device cleared through the 510(k) pathway via substantial equivalence to a legally marketed predicate.

K130006 · Cook Biotech Incorporated · Obstetrics & Gynecology device
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Apr 2013
Decision
93d
Days
Class 3
Risk

K130006 is an FDA 510(k) clearance for the BIODESIGN SURGISIS ANTERIOR POSTERIOR PELVIC FLOOR GRAFTS. Classified as Mesh, Surgical, Non-synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed (product code PAI), Class III - Premarket Approval.

Submitted by Cook Biotech Incorporated (West Lafayette, US). The FDA issued a Cleared decision on April 5, 2013 after a review of 93 days - within the typical 510(k) review window.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5980 - 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: 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.

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Submission Details

510(k) Number K130006 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 2013
Decision Date April 05, 2013
Days to Decision 93 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
67d faster than avg
Panel avg: 160d · This submission: 93d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code PAI Mesh, Surgical, Non-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 And Uterine Prolapse Repair Completed 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.