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510(k) K890264

STRABISMUS SCISSORS by Kinetic Medical Products — Product Code LRW

K890264 is an FDA 510(k) premarket notification submitted by Kinetic Medical Products for the device "STRABISMUS SCISSORS". The FDA issued a decision of Substantially Equivalent on January 27, 1989. The device falls under product code LRW (Scissors, General, Surgical), a Class I device regulated under 21 CFR 878.4800. Kinetic Medical Products has at least 10 other 510(k) clearances on record.

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
Scissors, General, 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)
  • K890382 — COMPRESSION FORCEPS (February 27, 1989)
  • K890380 — CERVICAL BIOPSY FORCEPS (February 27, 1989)
  • K890376 — VAGINAL SPECULUM (February 27, 1989)
  • K890387 — MALLEABLE PLACENTA CURETTE (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)
  • K890377 — FIXED-SIZE UTERINE DILATOR (February 13, 1989)

Other clearances for product code LRW

  • K911158 — MICRO SCISSORS, 5MM CURVE MICRO SCISSORS, 5MM (March 29, 1991)
  • K902828 — SUTURE REMOVAL TRAY (August 8, 1990)
  • K900950 — GS-2000 MICRO SCISSOR, CURVED LEFT, 5MM (April 18, 1990)
  • K900957 — GS-2100 HOOK SUTURE SCISSOR, 5MM (April 18, 1990)
  • K892823 — PLASTER CUTTING SCISSORS (May 25, 1989)
  • K891886 — SCISSORS, VARIOUS TYPES (April 12, 1989)
  • K891889 — OLIVECORONA SCISSORS (April 12, 1989)
  • K891200 — RIBBON TYPE SCISSORS: TENOTOMY,IRIS,EYE,STRABISMUS (April 6, 1989)
  • K891203 — SCISSORS: THOREK, JORGENSEN, FINOCHIETTO (April 6, 1989)
  • K890170 — SCISSORS (February 3, 1989)

FDA data resources