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510(k) K873501

SCISSOR, LEFT by Arthropedics, Inc. — Product Code HRR

K873501 is an FDA 510(k) premarket notification submitted by Arthropedics, Inc. for the device "SCISSOR, LEFT". The FDA issued a decision of Substantially Equivalent on November 2, 1987. The device falls under product code HRR (Scissors, Orthopedic, Surgical), 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
August 31, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Scissors, Orthopedic, Surgical
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)
  • K873713 — TRIANGULAR KNIFE, DISPOSABLE #TM-1611 (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)
  • K873510 — SERRATED GRASPING FORCEPS, CURVED DOWN (November 2, 1987)

Other clearances for product code HRR

  • K890212 — MICROSURGICAL SCISSORS (January 27, 1989)
  • K890261 — TRIGEMINAL SCISSORS (January 27, 1989)
  • K890225 — SURGICAL SCISSORS (January 27, 1989)
  • K873502 — SCISSOR, RIGHT (November 2, 1987)
  • K851800 — 69-100 TO 69-114 VARIOUS CUTICLE SCISSORS (June 20, 1985)
  • K842953 — ALL-HANDS MEDICAL SUPPLY SUTURE REMOVAL (August 21, 1984)
  • K800721 — GENERAL UTILITY SURG. SCISSORS #460180- (May 8, 1980)

FDA data resources