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510(k) K890256

BONE RONGEUR, DOUBLE-ACTION by Kinetic Medical Products — Product Code EMH

K890256 is an FDA 510(k) premarket notification submitted by Kinetic Medical Products for the device "BONE RONGEUR, DOUBLE-ACTION". The FDA issued a decision of Substantially Equivalent on January 27, 1989. The device falls under product code EMH (Forceps, Rongeur, Surgical), a Class I device regulated under 21 CFR 872.4565. 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
Forceps, Rongeur, Surgical
Device Class
Class I
Regulation Number
872.4565
Review Panel
DE
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 EMH

  • K890255 — BONE RONGEUR, SINGLE-ACTION (January 27, 1989)
  • K854887 — MANU/SURG INST/ACCESS WUERZBURG TIT MINI BONE PLAT (February 28, 1986)
  • K851710 — 586 TO 596 VARIOUS TYPES DENTAL ROOT SPLINTER FORC (June 11, 1985)
  • K834190 — JAKOBI SURG. INSTRUMENTS #8 15 (March 6, 1984)
  • K834366 — SURGICAL INSTRUMENTS & ACCESSORIES (February 27, 1984)
  • K821358 — MODIFIED RONGEURS FOR SPINAL & ORTH. S. (May 28, 1982)
  • K771522 — FORCEPS, STYLE #849 (August 16, 1977)

FDA data resources