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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 Dec 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 15 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Dec 24, 1985
Date Received
Dec 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
510(k) Exempt

Other clearances by Euro-Med Intl.

  • K883884 — PROSTATIC CORE-CUT NEEDLE (Dec 5, 1988)
  • K882404 — KEVOR-CURETTE (Jul 8, 1988)
  • K854891 — KNIFE (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)
  • K854901 — PACIFIC GRASPER (May 2, 1986)
  • K854897 — MAX-I-GRASP (May 2, 1986)

Other clearances for product code FZS

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

FDA data resources