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510(k) K890221

MICROSURGICAL WIRE LOOP by Kinetic Medical Products — Product Code JYQ

K890221 is an FDA 510(k) premarket notification submitted by Kinetic Medical Products for the device "MICROSURGICAL WIRE LOOP". The FDA issued a decision of Substantially Equivalent on January 27, 1989. The device falls under product code JYQ (Loop, Wire), a Class I device regulated under 21 CFR 874.4420. 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
Loop, Wire
Device Class
Class I
Regulation Number
874.4420
Review Panel
EN
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 JYQ

  • K870761 — EAR LOOP (March 3, 1987)

FDA data resources