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510(k) K202799

EVA15 by Palliare , Ltd. — Product Code HIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 21, 2020
Date Received
September 23, 2020
Clearance Type
Special
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)
  • K222901 — EVA15 insufflator (January 27, 2023)
  • K202922 — END 200 Endoscopic Tubeset (July 8, 2021)
  • 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)
  • 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)