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510(k) K931476

NOVY CORNUAL CANNULATION SET by Cook Ob/Gyn — Product Code MOV

K931476 is an FDA 510(k) premarket notification submitted by Cook Ob/Gyn for the device "NOVY CORNUAL CANNULATION SET". The FDA issued a decision of Substantially Equivalent on July 28, 1995. The device falls under product code MOV (Catheters, Salpingography), a Class II device regulated under 21 CFR 884.4530. Cook Ob/Gyn has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 1995
Date Received
March 24, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheters, Salpingography
Device Class
Class II
Regulation Number
884.4530
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 MOV

  • K180552 — Modified Novy Cornual Cannulation Set (July 12, 2018)
  • K932436 — ECHOMARK INTRAUTERINE GUIDING CATHETER (November 16, 1995)
  • K931534 — OVAMED INTRAUTERINE ACCESS CATHETER (July 28, 1995)
  • K953314 — CONCEPTUS FALLOPIAN TUBE CATHETERIZATION SYSTEM (July 28, 1995)

FDA data resources