I-STOP

Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator

CL MEDICAL

The following data is part of a premarket notification filed by Cl Medical with the FDA for I-stop.

Pre-market Notification Details

• Device ID: K051533
• 510k Number: K051533
• Device Name: I-STOP
• Classification: Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
• Applicant: CL MEDICAL 28 AVENUE GENERAL DE GAULLE Sainte Foy Les Lyon, FR 69110
• Contact: Vincent Goria
• Correspondent: Vincent Goria; CL MEDICAL 28 AVENUE GENERAL DE GAULLE Sainte Foy Les Lyon, FR 69110
• Product Code: OTN
• CFR Regulation Number: 878.3300 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2005-06-09
• Decision Date: 2005-08-11
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
03760151650338	K051533	000
03760151650185	K051533	000
03760151650093	K051533	000
03760151650055	K051533	000
03760151650048	K051533	000