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510(k) K890383

HYSTERECTOMY FORCEPS by Kinetic Medical Products — Product Code HCZ

K890383 is an FDA 510(k) premarket notification submitted by Kinetic Medical Products for the device "HYSTERECTOMY FORCEPS". The FDA issued a decision of Substantially Equivalent on February 16, 1989. The device falls under product code HCZ (Forceps, Surgical, Gynecological), a Class II device regulated under 21 CFR 884.4530. Kinetic Medical Products has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 16, 1989
Date Received
January 23, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Forceps, Surgical, Gynecological
Device Class
Class II
Regulation Number
884.4530
Review Panel
OB
Submission Type

Other clearances by Kinetic Medical Products

  • K890385 — MIDWIFERY/OBSTETRICAL FORCEPS (March 1, 1989)
  • K890376 — VAGINAL SPECULUM (February 27, 1989)
  • K890380 — CERVICAL BIOPSY FORCEPS (February 27, 1989)
  • K890387 — MALLEABLE PLACENTA CURETTE (February 27, 1989)
  • K890382 — COMPRESSION FORCEPS (February 27, 1989)
  • K890216 — MICROSURGICAL KERATOME (February 16, 1989)
  • K890384 — UTERINE CURETTE (February 13, 1989)
  • K890389 — UMBILICAL SCISSORS (February 13, 1989)
  • K890378 — UTERINE DRESSING FORCEPS (February 13, 1989)
  • K890388 — CEPHALOTOMY SCISSORS (February 13, 1989)

Other clearances for product code HCZ

  • K172661 — Fetzer Medical Gynecological Forceps (May 8, 2018)
  • K134047 — JARIT GYNECOLOGICAL FORCEPS, MILTEX GYNECOLOGICAL FORCEPS, MEISTERHAND GYNECOLOI (April 11, 2014)
  • K092840 — INSTRUMED FORCEPS OBSTETRICAL/GYNAECOLOGICAL (December 3, 2009)
  • K944055 — FORCEPS, SURGICAL GYNECOLOGICAL (September 20, 1994)
  • K941528 — PEARL PACKING FORCEPS (May 12, 1994)
  • K926533 — Z-CLAMP FORCEPS (February 25, 1994)
  • K926484 — CORSON MYOMA GRASPING FORCEPS (February 25, 1994)
  • K926531 — HYSTERECTOMY FORCEPS (February 25, 1994)
  • K930799 — VARIOUS FORCEPS (February 24, 1994)
  • K930039 — FORCEPS: MCGRAVEY, MCINDOE, GILLIS (February 24, 1994)

FDA data resources