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510(k) K890301

SHEPARD INTRAUTERINE INSEMINATION CATHETER by Cook Ob/Gyn — Product Code HDR

K890301 is an FDA 510(k) premarket notification submitted by Cook Ob/Gyn for the device "SHEPARD INTRAUTERINE INSEMINATION CATHETER". The FDA issued a decision of Substantially Equivalent on March 31, 1989. The device falls under product code HDR (Cap, Cervical), a Class II device regulated under 21 CFR 884.5250. Cook Ob/Gyn has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 1989
Date Received
January 23, 1989
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

Other clearances by Cook Ob/Gyn

  • K062438 — BAKRI POSTPARTUM BALLOON, MODEL J-SOS-100500 (October 27, 2006)
  • K030441 — SYDNEY IVF BLASTOCYST CRYOPRESERVATION KIT AND SYDNEY IVF BLASTOCYST THAW KIT (August 29, 2003)
  • 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)
  • K902694 — COAXIAL CATHETER SET (August 28, 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)

FDA data resources