Home / 510(k) Clearances / K170799

510(k) K170799

AP 50/30 Insufflator with Insuflow Port by Lexion Medical, LLC — Product Code HIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 14, 2017
Date Received
March 17, 2017
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 Lexion Medical, LLC

  • K191780 — AP50/30 Insufflator with Insuflow Port (August 28, 2019)
  • K140263 — INSUFLOW SYNERGY PORT, INSUFLOW SYNERGY XL PORT (March 5, 2014)
  • K132203 — PNEUVIEW XE VERYCLEAR GAS EVACUATION CANNULA (September 20, 2013)
  • K132204 — INSUFLOW SYNERGY XL PORT (August 22, 2013)
  • K120640 — INSUFLOW SYNERGY PORT (July 18, 2012)
  • K112357 — VESSEL GUARDIAN (November 10, 2011)
  • K102136 — VESSEL GUARDIAN (September 27, 2010)
  • K101320 — VASOVAPOR (June 24, 2010)
  • K091366 — INSUFLOW DEWHEART (September 3, 2009)
  • K090456 — INSUFLOW (August 26, 2009)

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)
  • 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)