Home / 510(k) Clearances / K873711

510(k) K873711

RETROGRADE KNIFE, DISPOSABLE #TM-1613 by Arthropedics, Inc. — Product Code HTS

K873711 is an FDA 510(k) premarket notification submitted by Arthropedics, Inc. for the device "RETROGRADE KNIFE, DISPOSABLE #TM-1613". The FDA issued a decision of Substantially Equivalent on November 2, 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
November 2, 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)
  • K873510 — SERRATED GRASPING FORCEPS, CURVED DOWN (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)
  • K873712 — STANDARD KNIFE, DISPOSABLE #TM-1610 (October 15, 1987)
  • K842820 — ARTHROSCOPY KNIVES (August 14, 1984)
  • K771851 — ARTHROSCOPE OPERATIVE KNIFE SET (October 27, 1977)

FDA data resources