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510(k) K890389

UMBILICAL SCISSORS by Kinetic Medical Products — Product Code HDJ

K890389 is an FDA 510(k) premarket notification submitted by Kinetic Medical Products for the device "UMBILICAL SCISSORS". The FDA issued a decision of Substantially Equivalent on February 13, 1989. The device falls under product code HDJ (Scissors, Umbilical), a Class I device regulated under 21 CFR 884.4520. Kinetic Medical Products has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 13, 1989
Date Received
January 23, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Scissors, Umbilical
Device Class
Class I
Regulation Number
884.4520
Review Panel
OB
Submission Type

Other clearances by Kinetic Medical Products

  • K890385 — MIDWIFERY/OBSTETRICAL FORCEPS (March 1, 1989)
  • K890382 — COMPRESSION FORCEPS (February 27, 1989)
  • K890387 — MALLEABLE PLACENTA CURETTE (February 27, 1989)
  • K890376 — VAGINAL SPECULUM (February 27, 1989)
  • K890380 — CERVICAL BIOPSY FORCEPS (February 27, 1989)
  • K890383 — HYSTERECTOMY FORCEPS (February 16, 1989)
  • K890216 — MICROSURGICAL KERATOME (February 16, 1989)
  • K890384 — UTERINE CURETTE (February 13, 1989)
  • K890378 — UTERINE DRESSING FORCEPS (February 13, 1989)
  • K890388 — CEPHALOTOMY SCISSORS (February 13, 1989)

FDA data resources