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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 Jun 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 28 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Jun 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
510(k) Exempt

Other clearances by Arthropedics, Inc.

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

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

FDA data resources