Home / 510(k) Clearances / K871925

510(k) K871925

STRAIGHT CUP CURRETTE, 1.7MM by Arthropedics, Inc. — Product Code FZS

K871925 is an FDA 510(k) premarket notification submitted by Arthropedics, Inc. for the device "STRAIGHT CUP CURRETTE, 1.7MM". The FDA issued a decision of Substantially Equivalent on June 1, 1987. The device falls under product code FZS (Curette, Surgical, General Use), a Class I device regulated under 21 CFR 878.4800. Arthropedics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 1, 1987
Date Received
May 18, 1987
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 Arthropedics, Inc.

  • K873619 — ARTHROSCOPIC RETENTION-MANIPULATION SYSTEM (ARMS) (January 14, 1988)
  • K873654 — MONOPOLAR CAUTERY CONICAL TIP #TM-1702 (December 15, 1987)
  • K873655 — MONOPOLAR CAUTERY RETROGADE TIP #TM-1703 (December 15, 1987)
  • K873653 — MONOPOLAR CAUTERY BLADE TIP #TM-1701 (December 15, 1987)
  • K873387 — VIDEO ARTHROSCOPE, 1.7MM X 55 MM (November 25, 1987)
  • K873501 — SCISSOR, LEFT (November 2, 1987)
  • K873503 — CUP BIOPSY FORCEPS, LEFT (November 2, 1987)
  • K873506 — CUP BIOPSY FORCEPS, CURVED UP (November 2, 1987)
  • K873711 — RETROGRADE KNIFE, DISPOSABLE #TM-1613 (November 2, 1987)
  • K873713 — TRIANGULAR KNIFE, DISPOSABLE #TM-1611 (November 2, 1987)

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)
  • K854899 — NOVAK CURETTE (December 24, 1985)
  • K854888 — RANDALL CURETTE (December 24, 1985)
  • K842701 — HOPPENSTEIN MICROSURGICAL SPINAL INSTRU (August 2, 1984)

FDA data resources