Cleared Special

SPARC SYSTEM AND MONARC, MONARC, AND MONARC C SYSTEMS

K131229 · American Medical Systems · Gastroenterology & Urology

Dec 2013

Decision

219d

Days

Class 2

Risk

About This 510(k) Submission

K131229 is an FDA 510(k) clearance for the SPARC SYSTEM AND MONARC, MONARC, AND MONARC C SYSTEMS, a Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator (Class II — Special Controls, product code OTN), submitted by American Medical Systems (Minnetonka, US). The FDA issued a Cleared decision on December 5, 2013, 219 days after receiving the submission on April 30, 2013. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 878.3300.

Submission Details

510(k) Number	K131229 FDA.gov
FDA Decision	Cleared 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

Device Classification

Product Code	OTN — Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
Device Class	Class II — 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