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510(k) K884553

STAMEY NEEDLE by Cook Ob/Gyn — Product Code GEJ

K884553 is an FDA 510(k) premarket notification submitted by Cook Ob/Gyn for the device "STAMEY NEEDLE". The FDA issued a decision of Substantially Equivalent on November 14, 1988. The device falls under product code GEJ (Carrier, Ligature), a Class I device regulated under 21 CFR 878.4800. Cook Ob/Gyn has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 14, 1988
Date Received
October 31, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Carrier, Ligature
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
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 GEJ

  • K240185 — Cypris eXact Suture Placement Device (May 3, 2024)
  • K900959 — GS-1400 TOOTHED DISSECTING FORCEP, 5MM, INSULATED (April 18, 1990)
  • K900958 — GS-1300 ATRAUMATIC GRASPING FORCEP, CURVED, 10MM (April 18, 1990)
  • K874342 — LIGATURE CARRIER/PACKER, HYDROXYLAPATITE (November 13, 1987)

FDA data resources