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510(k) K222901

EVA15 insufflator by Palliare , Ltd. — Product Code HIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 27, 2023
Date Received
September 23, 2022
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 Palliare , Ltd.

  • K232902 — EVA15 insufflator (May 2, 2024)
  • K230474 — EVA5 Insufflator (March 24, 2023)
  • K202922 — END 200 Endoscopic Tubeset (July 8, 2021)
  • K202799 — EVA15 (October 21, 2020)
  • K193520 — EVA 15 Insufflator (July 23, 2020)

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)
  • K230239 — AirSeal iFS System; AirSeal dV Solution (September 20, 2023)
  • K231342 — Insufflator (OPTO-IFL1000) (September 20, 2023)