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510(k) K132203

PNEUVIEW XE VERYCLEAR GAS EVACUATION CANNULA by Lexion Medical, LLC — Product Code HIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 2013
Date Received
July 16, 2013
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

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  • 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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  • 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)