Cleared Abbreviated

K071957 - PINNACLE PELVIC FLOOR REPAIR KITS

K071957 is the FDA 510(k) clearance for PINNACLE PELVIC FLOOR REPAIR KITS by Boston Scientific Corp. It is a Class 3 Obstetrics & Gynecology device (product code OTP) cleared through the Abbreviated 510(k) pathway after a 115-day FDA review.

K071957 · Boston Scientific Corp · Obstetrics & Gynecology device
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Optimized for regulatory review, auditing and printing
Nov 2007
Decision
115d
Days
Class 3
Risk

K071957 is an FDA 510(k) clearance for the PINNACLE PELVIC FLOOR REPAIR KITS. Classified as Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed (product code OTP), Class III - Premarket Approval.

Submitted by Boston Scientific Corp (Marlboro, US). The FDA issued a Cleared decision on November 8, 2007 after a review of 115 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

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 Boston Scientific Corp devices

Submission Details

510(k) Number K071957 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 2007
Decision Date November 08, 2007
Days to Decision 115 days
Submission Type Abbreviated
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
45d faster than avg
Panel avg: 160d · This submission: 115d
Pathway characteristics
Standards-based clearance path.

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
Devices cleared under the same product code (OTP) and FDA review panel - the closest regulatory comparables to K071957.
GYNECARE PROLIFT +M* PELVIC FLOOR REPAIR SYSTEMS
K071512 · Ethicon, Inc. · May 2008
AMS ELEVATE WITH INTEPRO LITE PROLAPSE REPAIR SYSTEM, AMS ELEVATE WITH INTEXEN LP PROLAPSE REPAIR SYSTEM
K080185 · American Medical Systems, Inc. · Apr 2008
PARIETENE DUO AND QUADRA POLYPROPYLENE MESHES
K072951 · Sofradim Production · Dec 2007
AVAULTA SUPPORT SYSTEM/AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM
K063712 · C.R. Bard, Inc. · Mar 2007
GYNECARE PROSIMA PELVIC FLOOR REPAIR SYSTEMS
K063562 · Ethicon, Inc. · Feb 2007
MENTOR NOVASILK MESH
K053414 · Mentor Corp. · Dec 2005