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510(k) K890211

MICROSURGICAL NEEDLE HOLDERS by Kinetic Medical Products — Product Code GDF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 27, 1989
Date Received
January 18, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Guide, Needle, Surgical
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Kinetic Medical Products

  • K890385 — MIDWIFERY/OBSTETRICAL FORCEPS (March 1, 1989)
  • K890387 — MALLEABLE PLACENTA CURETTE (February 27, 1989)
  • K890380 — CERVICAL BIOPSY FORCEPS (February 27, 1989)
  • K890382 — COMPRESSION FORCEPS (February 27, 1989)
  • K890376 — VAGINAL SPECULUM (February 27, 1989)
  • K890216 — MICROSURGICAL KERATOME (February 16, 1989)
  • K890383 — HYSTERECTOMY FORCEPS (February 16, 1989)
  • K890379 — UTERINE TENTACULUM (February 13, 1989)
  • K890377 — FIXED-SIZE UTERINE DILATOR (February 13, 1989)
  • K890378 — UTERINE DRESSING FORCEPS (February 13, 1989)

Other clearances for product code GDF

  • K031173 — NEEDLETECH GUIDEWIRE INTRODUCER NEEDLE, MODELS 40021, 40069, 40053, 40042 & 4001 (July 23, 2003)
  • K950311 — GLOBAL MEDICAL PRODUCTS BREST LESION LOCALIZATION NEEDLE WITH STIFFENED WIRE (May 26, 1995)
  • K950007 — SURGICAL INSTRUMENT GUIDE (March 15, 1995)
  • K945124 — BREAST LESION LOCALIZATION NEEDLE (November 22, 1994)
  • K944942 — BREAST LESION LOCALIZATION NEEDLE (November 4, 1994)
  • K935538 — BAUER TEMNO COAXIAL NEEDLE (February 22, 1994)
  • K935457 — LOCALIZATION WIRE OR MARKER - SURGICAL (February 17, 1994)
  • K923840 — NEEDLE-GRABBER (July 13, 1993)
  • K923835 — THE ELEVENTH FINGER (July 9, 1993)
  • K925875 — HORIZONTAL NEEDLE GUIDE ATTACHMENT (April 6, 1993)