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510(k) K201832

Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5 by Olympus Medical Systems Corp. — Product Code HET

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 17, 2021
Date Received
July 2, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laparoscope, Gynecologic (And Accessories)
Device Class
Class II
Regulation Number
884.1720
Review Panel
OB
Submission Type

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Other clearances for product code HET

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  • K210104 — SurroundScope System (July 8, 2021)
  • K201617 — TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera (March 12, 2021)
  • K200216 — 4K UHD Camera System (August 21, 2020)
  • K200638 — LAP-iX Suction Irrigation (April 3, 2020)
  • K190190 — WV1 Endoscope (November 1, 2019)
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