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510(k) K890385

MIDWIFERY/OBSTETRICAL FORCEPS by Kinetic Medical Products — Product Code HDA

K890385 is an FDA 510(k) premarket notification submitted by Kinetic Medical Products for the device "MIDWIFERY/OBSTETRICAL FORCEPS". The FDA issued a decision of Substantially Equivalent on March 1, 1989. The device falls under product code HDA (Forceps, Obstetrical), a Class II device regulated under 21 CFR 884.4400. Kinetic Medical Products has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 1, 1989
Date Received
January 23, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Forceps, Obstetrical
Device Class
Class II
Regulation Number
884.4400
Review Panel
OB
Submission Type

Other clearances by Kinetic Medical Products

  • K890387 — MALLEABLE PLACENTA CURETTE (February 27, 1989)
  • K890376 — VAGINAL SPECULUM (February 27, 1989)
  • K890380 — CERVICAL BIOPSY FORCEPS (February 27, 1989)
  • K890382 — COMPRESSION FORCEPS (February 27, 1989)
  • K890383 — HYSTERECTOMY FORCEPS (February 16, 1989)
  • K890216 — MICROSURGICAL KERATOME (February 16, 1989)
  • K890389 — UMBILICAL SCISSORS (February 13, 1989)
  • K890388 — CEPHALOTOMY SCISSORS (February 13, 1989)
  • K890378 — UTERINE DRESSING FORCEPS (February 13, 1989)
  • K890377 — FIXED-SIZE UTERINE DILATOR (February 13, 1989)

Other clearances for product code HDA

  • K100517 — INSTRUMED FORCEPS OBSTERICAL, MODEL# 46-5XXX, OB-XXXX (April 29, 2010)
  • K092827 — DIMELA OBSTERICAL FORCEPS, MODEL 72.1 XX XX (January 8, 2010)
  • K013747 — TEKNO-MEDICAL OBSTETRICAL FORCEPS (February 11, 2002)
  • K951529 — V. MUELLER OBSTETRICAL (OB) FORCEPS (August 4, 1995)
  • K914552 — CMI VACUUM PUMP (September 7, 1993)
  • K905583 — ILC FORCEPS PADS (April 12, 1991)
  • K903205 — AUTO SUTURE(R) ENDOSCOPIC CLAMP (October 11, 1990)
  • K851883 — SIMPSON OBSTETRICAL FORCEPS-SS TYPE 410 OR 420 (May 9, 1985)
  • K771106 — FORCEPS, OB, NON-COMPRESSIVE (July 1, 1977)

FDA data resources