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510(k) K902694

COAXIAL CATHETER SET by Cook Ob/Gyn — Product Code HDR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 28, 1990
Date Received
June 19, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cap, Cervical
Device Class
Class II
Regulation Number
884.5250
Review Panel
OB
Submission Type

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  • K023850 — SYDNEY IVF EMBRYO BIOPSY MEDIUM (January 22, 2003)
  • K013597 — TAMPONADE UTERINE BALLOON CATHETER SET (April 17, 2002)
  • K002385 — COOK IVF FOLLICLE FLUSHING BUFFER, COOK IVF OOCYTE WASH BUFFER, COOK IVF FERTILI (September 18, 2000)
  • K002383 — COOK IVF SPERM BUFFER, COOK IVF SPERM MEDIUM, AND COOK IVF SPERM GRADIENT KIT (September 13, 2000)
  • K983595 — TRANSMYOMETRIAL EMBRYO TRANSFER SET (February 8, 1999)
  • K983596 — INTRACYTOPLASMIC SPERM INJECTION (ICSI) MICRO-INJECTION PIPETTES, HOLDING PIPETT (February 5, 1999)
  • K983642 — COOK MINI-INCUBATOR (February 1, 1999)
  • K983593 — OVUM PICK-UP ASPIRATION NEEDLES (January 21, 1999)

Other clearances for product code HDR

  • K242031 — Béa Applicator (BAP-GB-01) (April 2, 2025)
  • K222969 — FERTI-LILY Conception Cup (June 23, 2023)
  • K993953 — OVES CERVICAL CAP (March 21, 2000)
  • K945131 — IMAGYN INTRAUTERINE INSEMINATION DEVICE (May 15, 1995)
  • K950714 — COOK INSEMINATION CUP (May 11, 1995)
  • K902171 — MINISPACE(TM) IUI CATHETER (October 5, 1990)
  • K896960 — INTRAUTERINE INSEMINATION CATHETERS (June 26, 1990)
  • K900316 — MODIFIED HAM'S F-10 MEDIUM AND MEDIUM-HEPES (April 16, 1990)
  • K900308 — SPERM SELECT SYSTEM (April 13, 1990)
  • K900162 — DGH A-SAN PROBE HOLDER (February 16, 1990)