Home / 510(k) Clearances / K193339

510(k) K193339

GTK Veress Needles by Guangzhou T.K Medical Instrument Co., Ltd. — Product Code HIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 2020
Date Received
December 2, 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 Guangzhou T.K Medical Instrument Co., Ltd.

  • K193272 — GTK Trocars (July 9, 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)
  • K230239 — AirSeal iFS System; AirSeal dV Solution (September 20, 2023)
  • K231342 — Insufflator (OPTO-IFL1000) (September 20, 2023)