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510(k) K932114

TUBAL LUMEN SUPPORT by Cook Ob/Gyn — Product Code HFJ

K932114 is an FDA 510(k) premarket notification submitted by Cook Ob/Gyn for the device "TUBAL LUMEN SUPPORT". The FDA issued a decision of Substantially Equivalent on September 27, 1994. The device falls under product code HFJ (Prosthesis, Fallopian Tube), a Class II device regulated under 21 CFR 884.3650. Cook Ob/Gyn has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 1994
Date Received
May 3, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Fallopian Tube
Device Class
Class II
Regulation Number
884.3650
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)

FDA data resources