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510(k) K191780

AP50/30 Insufflator with Insuflow Port by Lexion Medical, LLC — Product Code HIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 28, 2019
Date Received
July 2, 2019
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

  • K170799 — AP 50/30 Insufflator with Insuflow Port (November 14, 2017)
  • 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)

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