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510(k) K891334

ACU-CURETTE by Acuderm, Inc. — Product Code FZS

K891334 is an FDA 510(k) premarket notification submitted by Acuderm, Inc. for the device "ACU-CURETTE". The FDA issued a decision of Substantially Equivalent on April 11, 1989. The device falls under product code FZS (Curette, Surgical, General Use), a Class I device regulated under 21 CFR 878.4800. Acuderm, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 11, 1989
Date Received
March 10, 1989
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 Acuderm, Inc.

  • K933516 — ACU-E PUNCH (March 24, 1994)
  • K933265 — ACU-DISPO-CE(TM) (March 7, 1994)
  • K933137 — ACU-SUTURE KIT (February 22, 1994)
  • K930043 — ACU-EVAC (February 9, 1994)
  • K933866 — ACU-HEMOSTATIC RING (December 1, 1993)
  • K915000 — ACU-GUARD (January 27, 1992)
  • K874024 — ACU-MICRO-NEEDLE (November 23, 1987)
  • K854877 — ACU-SYRINGE W/WO NEEDLES (February 19, 1986)
  • K832582 — MYCOSEL AGAR (September 12, 1983)
  • K832581 — DTM-DERMATOPHYTE TEST MEDIUM (September 12, 1983)

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)
  • 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)
  • K854888 — RANDALL CURETTE (December 24, 1985)
  • K842701 — HOPPENSTEIN MICROSURGICAL SPINAL INSTRU (August 2, 1984)

FDA data resources