FDA.reportPublic FDA data

510(k) K052175

Device
I-STOP MID-URETHRAL SLING, MODELS IS-1000, IS-2000, IS-3000, IS-4000
Applicant
Uroplasty, Inc.
510(k) number
K052175
Product code
OTN
Decision
Substantially Equivalent (SESE)
Decision date
2005-10-17
Date received
2005-08-10
Regulation
878.3300
Classification name
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
Medical specialty
General, Plastic Surgery
Review panel
General, Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
MICHAEL MORRELL
Address
2718 Summer St. NE Minneapolis MN US 55413 55413

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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