FDA 510(k) K101847, URGENT PC STIMULATOR; URGENT PC LEAD SET, by Uroplasty, Inc.
FDA 510(k) K101847, URGENT PC STIMULATOR; URGENT PC LEAD SET, by Uroplasty, Inc.
Device Classification Name: Stimulator, Peripheral Nerve, Non-Implanted, For Urinary Incontinence
510(k) Number: K101847
Device Name: URGENT PC STIMULATOR; URGENT PC LEAD SET
Applicant: Uroplasty, Inc.
Regulation Number: 876.5310
Classification Product Code: NAM
Date Received: 07/01/2010
Decision Date: 10/21/2010
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
510k Review Panel: Gastroenterology/Urology
Total number of pages: 368
Fully redacted pages: 212
Content pages: 156
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