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510(k) K112357

VESSEL GUARDIAN by Lexion Medical, LLC — Product Code HIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 10, 2011
Date Received
August 16, 2011
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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  • 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)
  • 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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  • K232401 — Disposable Veress Needles (December 14, 2023)
  • K231342 — Insufflator (OPTO-IFL1000) (September 20, 2023)
  • K230239 — AirSeal iFS System; AirSeal dV Solution (September 20, 2023)