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510(k) K900878

OTT INSUFFLATION FILTER TUBING by Gynescope Corp. — Product Code HIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 7, 1990
Date Received
February 26, 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 Gynescope Corp.

  • K902657 — GYNESCOPE LAPAROSCOPIC FORCEPS (September 19, 1990)
  • K902658 — GYNESCOPE MONOPOLAR FORCEPS AND ELECTRODES (September 19, 1990)
  • K901530 — WALLACE INTRAUTERINE INSEMINATION CATHETER (July 23, 1990)
  • K902655 — GYNESCOPE LAPAROSCOPES (July 13, 1990)
  • K902656 — GYNESCOPE LAPAROSCOPIC TROCARS AND SLEEVES (June 29, 1990)
  • K902049 — CROAK OVARIAN BIOPSY FORCEP (June 7, 1990)
  • K902019 — MODIFIED METAL SPECULUM & SPECIAL BULLET FORCEPS (June 7, 1990)
  • K895225 — GYNECOLOGICAL INSTRUMENTATION (March 5, 1990)

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  • 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)