Home / 510(k) Clearances / K905549

510(k) K905549

THE DART by Dexide, Inc. — Product Code HIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 19, 1991
Date Received
December 11, 1990
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 Dexide, Inc.

  • K991814 — MULTACHOICE INSTRUMENTS (June 23, 1999)
  • K990379 — MODIFICATION TO MULTAPORT CANNULA, REDUCER AND ACCESSORIES (March 4, 1999)
  • K981940 — MULTAPUMP DISPOSABLE PUMP HEAD AND ACCESSORIES (September 25, 1998)
  • K981941 — MULTAPORT CANNULA REDUCER AND ACCESSORIES (July 29, 1998)
  • K953611 — DEXIDE ENDO-LUBE KIT (September 15, 1995)
  • K944509 — DEXIDE INSUFFLATION TUBING WITH FILTER (February 7, 1995)
  • K924117 — DEXIDE LAPAROSCOPIC KITS (March 23, 1993)
  • K923845 — DEXIDE LAPAROSCOPIC ACCESSORIES (November 25, 1992)
  • K921709 — ENDOBAG, MODIFICATION (July 14, 1992)
  • K913762 — MONOSCOPY(TM) BRAND, ENDOBAG (October 28, 1991)

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)