Cleared Special

SUPRIS RETROPUBIC SLING SYSTEM

K111233 · Coloplast A/S · Gastroenterology & Urology

Jun 2011

Decision

53d

Days

Class 2

Risk

About This 510(k) Submission

K111233 is an FDA 510(k) clearance for the SUPRIS RETROPUBIC SLING SYSTEM, a Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator (Class II — Special Controls, product code OTN), submitted by Coloplast A/S (Plymouth, US). The FDA issued a Cleared decision on June 24, 2011, 53 days after receiving the submission on May 2, 2011. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 878.3300.

Submission Details

510(k) Number	K111233 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 02, 2011
Decision Date	June 24, 2011
Days to Decision	53 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