Cleared Special

K112386 - EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEM

K112386 is an FDA 510(k) clearance for EXAIR ANTERIOR AND POSTERIOR PROLAPSE R..., manufactured by Coloplast Corp.. The device is a Class 3 Obstetrics & Gynecology device with product code OTP cleared through the Special 510(k) pathway after a 21-day FDA review.

K112386 · Coloplast Corp. · Obstetrics & Gynecology device
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Optimized for regulatory review, auditing and printing
Sep 2011
Decision
21d
Days
Class 3
Risk

K112386 is an FDA 510(k) clearance for the EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEM. Classified as Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed (product code OTP), Class III - Premarket Approval.

Submitted by Coloplast Corp. (Minneapolis, US). The FDA issued a Cleared decision on September 8, 2011 after a review of 21 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 Coloplast Corp. devices

FDA 510(k) Submission Details - K112386

510(k) Number K112386 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 2011
Decision Date September 08, 2011
Days to Decision 21 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
139d faster than avg
Panel avg: 160d · This submission: 21d
Pathway characteristics
Modification to existing cleared device.

OTP Device Classification - Class 3, Premarket Approval

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 26
Devices cleared under the same product code (OTP) and FDA review panel - the closest regulatory comparables to K112386.
ELEVATE PROLAPSE REPAIR SYSTEMS-APICAL NEEDLE PASSER SHEATH MODIFICATION
K121612 · American Medical Systems · Jul 2012
AMS ELEVATE PC
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LITE PELVIC FLOOR REPAIR KITS
K103426 · Boston Scientific Corp · Sep 2011
AMS ELEVATE PC APICAL AND POSTERIOR ( AND ANTERIOR AND APICAL) PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE
K111118 · American Medical Systems · Jul 2011
EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEMS
K083499 · Coloplast A/S · May 2009
PELVIC FLOOR REPAIR SYSTEM
K091131 · Boston Scientific · May 2009