FDA 510(k), K201832, Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5

FDA 510(k), K201832, Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5

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510(K) Number: K201832
Device Name: Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5
Manufacturer: Olympus Medical Systems Corp.
Device Classification Name: Laparoscope, Gynecologic (And Accessories)
Regulation Number: 884.1720
Classification Product Code: HET
Date Received: 07/02/2020
Decision Date: 09/17/2021
Regulation Medical Specialty: Obstetrics/Gynecology
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

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