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.

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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

PLEASE NOTE: Most 510(k)s obtained through FOIA are heavily redacted, often omitting sections related to testing, software, manufacturing, and other technical data. Please be sure to review the total pages, redacted pages, and content pages listed in the description to get a sense of how much of the document is redacted. As the FDA FOIA office explains: “We HEAVILY REDACT the majority of the following portions of 510(k) filings: testing data, technical data, lab reports, manufacturing information, vendor information, substantive discussions regarding deficiencies or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.” If you’d like more details about a specific document before purchasing, please contact us at info@foiadocs.com.

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