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510(k) K854888

RANDALL CURETTE by Euro-Med Intl. — Product Code FZS

K854888 is an FDA 510(k) premarket notification submitted by Euro-Med Intl. for the device "RANDALL CURETTE". The FDA issued a decision of Substantially Equivalent on December 24, 1985. The device falls under product code FZS (Curette, Surgical, General Use), 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
December 24, 1985
Date Received
December 6, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Curette, Surgical, General Use
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)
  • K854896 — HOOK SCISSOR (May 2, 1986)
  • K854894 — SPOON (May 2, 1986)
  • K854890 — HOOK PROBE (May 2, 1986)
  • K854895 — BASKET FORCEP (May 2, 1986)
  • K854891 — KNIFE (May 2, 1986)
  • K854897 — MAX-I-GRASP (May 2, 1986)
  • K854898 — ATLANTIC GRASPER (May 2, 1986)

Other clearances for product code FZS

  • K932493 — SURGICAL CURETTE (January 7, 1994)
  • K902000 — KEVTEK(TM) LASER DRAPE/ORGAN PROTECTOR/EYE SHIELD (August 21, 1990)
  • K892521 — CYMED MICROSKIN(R) DISPOSABLE IRRIGATION SLEEVE (May 1, 1989)
  • K891888 — CURRETTES - PIFFARD, WOLF, VIDAL-SCRAPER (April 12, 1989)
  • K891334 — ACU-CURETTE (April 11, 1989)
  • K890366 — ADENOID CURETTE (February 3, 1989)
  • K875292 — MICRODISCECTOMY CURETTE SET (January 29, 1988)
  • K871925 — STRAIGHT CUP CURRETTE, 1.7MM (June 1, 1987)
  • K854899 — NOVAK CURETTE (December 24, 1985)
  • K842701 — HOPPENSTEIN MICROSURGICAL SPINAL INSTRU (August 2, 1984)

FDA data resources