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510(k) K250388

ENDOFLATOR + by Karl Storz SE & CO. KG — Product Code HIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 22, 2025
Date Received
February 11, 2025
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

  • K242772 — AirSurgN Insufflator (10030/AirSurgN) (April 11, 2025)
  • K243527 — High Flow Insufflation Unit (UHI-4) (January 13, 2025)
  • K242536 — TauTona Pneumoperitoneum Assist Device (TPAD) (October 15, 2024)
  • K232464 — VereSee Optical Veres Needle System (May 2, 2024)
  • K232902 — EVA15 insufflator (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)