FDA 510(k), K142556, Flexible Video-Uretero-Choledochoscope System

FDA 510(k), K142556, Flexible Video-Uretero-Choledochoscope System

Regular price $415.84 USD
Regular price Sale price $415.84 USD
Sale Sold out

510(K) Number: K142556
Device Name: Flexible Video-Uretero-Choledochoscope System
Manufacturer: KARL STORZ ENDOSCOPY-AMERICA, INC.
Device Classification Name: ureteroscope and accessories, flexible/rigid
Regulation Number: 876.1500
Classification Product Code: FGB
Date Received: 09/11/2014
Decision Date: 10/23/2014
Regulation Medical Specialty: Gastroenterology/Urology

Total pages: 236
Fully redacted pages: 86
Content pages: 150

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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.

View full details