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510(k) K170453

Medrobotics Flex Robotic System by Medrobotics Corporation — Product Code EOB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 19, 2017
Date Received
February 15, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nasopharyngoscope (Flexible Or Rigid)
Device Class
Class II
Regulation Number
874.4760
Review Panel
EN
Submission Type

If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Other clearances by Medrobotics Corporation

  • K172796 — Flex Robotic System and Flex Transabdominal Drive (January 18, 2018)
  • 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)

Other clearances for product code EOB

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  • K243639 — Portare System (FA-001) (June 5, 2025)
  • K243380 — VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OLYMPUS OTV-S500) (March 3, 2025)
  • K234096 — MonoStereo (September 19, 2024)
  • K232435 — Rhinolaryngoscope system (April 26, 2024)
  • K232015 — ATMOS Scope (507.7000.0); ATMOS Scope Pro (507.7050.0); ATMOS Scope iPrime (507. (August 3, 2023)
  • K222587 — PatCom Distal Chip Endoscope (July 28, 2023)
  • K230536 — Single-use Flexible Rhinolaryngoscope; Digital Video Monitor (June 14, 2023)
  • K221660 — RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE-XP (December 28, 2022)
  • K221581 — Single-Use Flexible Rhinolaryngoscope (November 18, 2022)