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510(k) K172796

Flex Robotic System and Flex Transabdominal Drive by Medrobotics Corporation — Product Code HET

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 18, 2018
Date Received
September 15, 2017
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

Other clearances by Medrobotics Corporation

  • K170453 — Medrobotics Flex Robotic System (October 19, 2017)
  • K172036 — Medrobotics Flex Robotic System (August 3, 2017)
  • K162330 — Flex Robotic System and Flex Colorectal Drive (May 4, 2017)
  • K150776 — Medrobotics Flex System (July 17, 2015)

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