Cleared Traditional

K063136 - NEEDLELESS SLING

K063136 is an FDA 510(k) clearance for NEEDLELESS SLING, manufactured by Specialities Remeex International, S.L.. The device is a Class 2 Gastroenterology & Urology device with product code PAH cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K063136 · Specialities Remeex International, S.L. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2006
Decision
64d
Days
Class 2
Risk

K063136 is an FDA 510(k) clearance for the NEEDLELESS SLING. Classified as Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-sling (product code PAH), Class II - Special Controls.

Submitted by Specialities Remeex International, S.L. (Minneapolis, US). The FDA issued a Cleared decision on December 19, 2006 after a review of 64 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 878.3300 - the FDA gastroenterology and urology 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Specialities Remeex International, S.L. devices

FDA 510(k) Submission Details - K063136

510(k) Number K063136 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 2006
Decision Date December 19, 2006
Days to Decision 64 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 130d · This submission: 64d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PAH Device Classification - Class 2, Special Controls

Product Code PAH Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-sling
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3300
Definition Transvaginal Surgical Repair Of Female Stress Urinary Incontinence (sui) Due To Intrinsic Sphincter Deficiency (isd) And/or Urethral Hypermobility.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - PAH Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-sling

All 12
Devices cleared under the same product code (PAH) and FDA review panel - the closest regulatory comparables to K063136.
AMS MINIARC SLING SYSTEM
K073703 · American Medical Systems, Inc. · Jan 2008
AMS MINIARC SLING SYSTEM
K071902 · American Medical Systems, Inc. · Aug 2007
AMS SINGLE INCISION SLING SYSTEM (SIS-0)
K070065 · American Medical Systems, Inc. · Mar 2007
GYNECARE TVT SECUR SYSTEM
K052401 · Ethicon, Inc. · Nov 2005