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510(k) K891290

SHOLKOFF BALLOON HYSTEROSALPINGOGRAPHY CATHETER by Cook Ob/Gyn — Product Code HES

K891290 is an FDA 510(k) premarket notification submitted by Cook Ob/Gyn for the device "SHOLKOFF BALLOON HYSTEROSALPINGOGRAPHY CATHETER". The FDA issued a decision of Substantially Equivalent on May 23, 1989. The device falls under product code HES (Insufflator, Carbon-Dioxide, Uterotubal (And Accessories)), a Class II device regulated under 21 CFR 884.1300. Cook Ob/Gyn has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 1989
Date Received
March 10, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Insufflator, Carbon-Dioxide, Uterotubal (And Accessories)
Device Class
Class II
Regulation Number
884.1300
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 HES

  • K140761 — KAHN UTERINE CANNULA, JARCHO UTERINE CANNULA, NEAL FALLOPIAN CANNULA (April 21, 2014)
  • K000340 — HYSTALOG HSG CATHETER (April 19, 2000)
  • K903209 — MAXI-FLOW INSUFFLATOR TUBING SET W/FILTER (December 21, 1990)
  • K903208 — MAXI-FLOW INSUFFLATOR TUBING SET (December 17, 1990)
  • K904473 — KRONNER MANIPUJECTOR (December 14, 1990)
  • K901413 — CORE DISPOSABLE INSUFFLATION TUBING (September 24, 1990)
  • K890869 — BARD HYSTEROSALPINGOGRAPHY CATHETERS (April 25, 1989)
  • K875137 — LAPAROFLATOR 3000, STANDARD AND ELECTRONIC (March 2, 1988)
  • K873515 — UTERINE INJECTOR 2MM (September 29, 1987)
  • K862310 — CABOT MEDICAL VARIABLE FLOW INSUFFLATOR (August 12, 1986)

FDA data resources