Home / 510(k) Clearances / K873712

510(k) K873712

STANDARD KNIFE, DISPOSABLE #TM-1610 by Arthropedics, Inc. — Product Code HTS

K873712 is an FDA 510(k) premarket notification submitted by Arthropedics, Inc. for the device "STANDARD KNIFE, DISPOSABLE #TM-1610". The FDA issued a decision of Substantially Equivalent on October 15, 1987. The device falls under product code HTS (Knife, Orthopedic), a Class I device regulated under 21 CFR 888.4540. Arthropedics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 15, 1987
Date Received
September 15, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Knife, Orthopedic
Device Class
Class I
Regulation Number
888.4540
Review Panel
OR
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)
  • K873711 — RETROGRADE KNIFE, DISPOSABLE #TM-1613 (November 2, 1987)
  • K873506 — CUP BIOPSY FORCEPS, CURVED UP (November 2, 1987)
  • K873503 — CUP BIOPSY FORCEPS, LEFT (November 2, 1987)
  • K873713 — TRIANGULAR KNIFE, DISPOSABLE #TM-1611 (November 2, 1987)

Other clearances for product code HTS

  • K930507 — CUSTOM ORTHOPAEDIC TRAYS (PACKS) (February 22, 1994)
  • K933921 — ACUFLEX DISPOSABLE KNIVES (January 26, 1994)
  • K882525 — SPINAL MICROKNIFE (September 22, 1988)
  • K873714 — BANANA KNIFE, DISPOSABLE #TM-1612 (November 2, 1987)
  • K873713 — TRIANGULAR KNIFE, DISPOSABLE #TM-1611 (November 2, 1987)
  • K873711 — RETROGRADE KNIFE, DISPOSABLE #TM-1613 (November 2, 1987)
  • K842820 — ARTHROSCOPY KNIVES (August 14, 1984)
  • K771851 — ARTHROSCOPE OPERATIVE KNIFE SET (October 27, 1977)

FDA data resources