Cleared Abbreviated

K103426 - LITE PELVIC FLOOR REPAIR KITS

K103426 is the FDA 510(k) clearance for LITE 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 296-day FDA review.

K103426 · Boston Scientific Corp · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2011
Decision
296d
Days
Class 3
Risk

K103426 is an FDA 510(k) clearance for the LITE 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 September 14, 2011 after a review of 296 days - an extended review cycle.

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 K103426 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 2010
Decision Date September 14, 2011
Days to Decision 296 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
136d slower than avg
Panel avg: 160d · This submission: 296d
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 21
Devices cleared under the same product code (OTP) and FDA review panel - the closest regulatory comparables to K103426.
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K090713 · American Medical Systems, Inc. · Apr 2009