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510(k) K854891

KNIFE by Euro-Med Intl. — Product Code EMF

K854891 is an FDA 510(k) premarket notification submitted by Euro-Med Intl. for the device "KNIFE". The FDA issued a decision of Substantially Equivalent on May 2, 1986. The device falls under product code EMF (Knife, Surgical), a Class I device regulated under 21 CFR 878.4800. Euro-Med Intl. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 1986
Date Received
December 6, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Euro-Med Intl.

  • K883884 — PROSTATIC CORE-CUT NEEDLE (December 5, 1988)
  • K882404 — KEVOR-CURETTE (July 8, 1988)
  • K854901 — PACIFIC GRASPER (May 2, 1986)
  • K854897 — MAX-I-GRASP (May 2, 1986)
  • K854898 — ATLANTIC GRASPER (May 2, 1986)
  • K854896 — HOOK SCISSOR (May 2, 1986)
  • K854894 — SPOON (May 2, 1986)
  • K854890 — HOOK PROBE (May 2, 1986)
  • K854895 — BASKET FORCEP (May 2, 1986)
  • K854889 — FLEX-I-GRASP (February 21, 1986)

Other clearances for product code EMF

  • K080133 — MOUNTABLE ENDOSCOPIC BLADE (March 13, 2008)
  • K982142 — MOUNTABLE ENDOSCOPIC KNIFE (December 30, 1998)
  • K890214 — MICROSURGERY RAZOR BLADE HOLDER (January 27, 1989)
  • K890215 — MICROSURGICAL SCARIFIER (January 27, 1989)
  • K890217 — MICROSURGICAL KNIVES (January 27, 1989)
  • K880094 — VAN-TEC ENDOPYELOTOMY KNIFE (February 29, 1988)
  • K863752 — VALTRAC (BAR) REMOVER DEVICE (October 24, 1986)
  • K863549 — REUSABLE/DISPOSABLE AUTOPSY KNIFE SET (September 30, 1986)
  • K861947 — SURGICAL KNIFE (June 6, 1986)
  • K851784 — 27-210 PLASTER KNIFE (REINER) (June 20, 1985)

FDA data resources