Cleared Special

K131229 - SPARC SYSTEM AND MONARC

K131229 is an FDA 510(k) clearance for SPARC SYSTEM AND MONARC, manufactured by American Medical Systems. The device is a Class 2 Gastroenterology & Urology device with product code OTN cleared through the Special 510(k) pathway after a 219-day FDA review.

K131229 · American Medical Systems · Gastroenterology & Urology device
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Dec 2013
Decision
219d
Days
Class 2
Risk

K131229 is an FDA 510(k) clearance for the SPARC SYSTEM AND MONARC, MONARC, AND MONARC C SYSTEMS. Classified as Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator (product code OTN), Class II - Special Controls.

Submitted by American Medical Systems (Minnetonka, US). The FDA issued a Cleared decision on December 5, 2013 after a review of 219 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 878.3300 - the FDA gastroenterology and urology 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: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all American Medical Systems devices

FDA 510(k) Submission Details - K131229

510(k) Number K131229 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 2013
Decision Date December 05, 2013
Days to Decision 219 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
89d slower than avg
Panel avg: 130d · This submission: 219d
Pathway characteristics
Modification to existing cleared device.

OTN Device Classification - Class 2, Special Controls

Product Code OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3300
Definition Surgical Treatment Of Female Stress Urinary Incontinence 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 - OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator

All 36
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