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510(k) K243527

High Flow Insufflation Unit (UHI-4) by Olympus Medical Systems Corporation — Product Code HIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 13, 2025
Date Received
November 14, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Insufflator, Laparoscopic
Device Class
Class II
Regulation Number
884.1730
Review Panel
OB
Submission Type

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Other clearances for product code HIF

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  • K232464 — VereSee Optical Veres Needle System (May 2, 2024)
  • K233020 — TauTona Pneumoperitoneum Assist Device (TPAD) (January 12, 2024)
  • K232401 — Disposable Veress Needles (December 14, 2023)
  • K231342 — Insufflator (OPTO-IFL1000) (September 20, 2023)
  • K230239 — AirSeal iFS System; AirSeal dV Solution (September 20, 2023)
  • K231407 — StarFin (August 29, 2023)