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510(k) K193520

EVA 15 Insufflator by Palliare , Ltd. — Product Code HIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 23, 2020
Date Received
December 19, 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 Palliare , Ltd.

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  • K202922 — END 200 Endoscopic Tubeset (July 8, 2021)
  • K202799 — EVA15 (October 21, 2020)

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