Home / 510(k) Clearances / K153513

510(k) K153513

Insufflator 50L FM134 by W.O.M. World of Medicine GmbH — Product Code HIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 4, 2016
Date Received
December 7, 2015
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

Other clearances by W.O.M. World of Medicine GmbH

  • K250795 — PUREVUE™ FMS (December 5, 2025)
  • K201361 — PNEUMOCLEAR (July 29, 2020)
  • K173311 — ARTHRO-Pump PA304 (May 9, 2018)
  • K173489 — GYN-Pump PH304 (March 28, 2018)
  • K172040 — Aquilex Fluid Control System AQL-100S (February 5, 2018)
  • K170784 — PNEUMOCLEAR (May 15, 2017)
  • K163320 — LAP-Pump PP110 (March 21, 2017)
  • K152109 — HD-Camera HDC1000 (October 13, 2015)
  • K123732 — HYSTEROSCOPY PUMP HM6 (April 4, 2013)
  • K112642 — AQUILEX FLUID CONTROL SYSTEM H112 (February 6, 2012)

Other clearances for product code HIF

  • K250388 — ENDOFLATOR + (September 22, 2025)
  • 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)
  • K232902 — EVA15 insufflator (May 2, 2024)
  • 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)