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510(k) K873651

BLUNT MEASURING PROBE W/2MM GRADATIONS #TM-1375 by Arthropedics, Inc. — Product Code HXB

K873651 is an FDA 510(k) premarket notification submitted by Arthropedics, Inc. for the device "BLUNT MEASURING PROBE W/2MM GRADATIONS #TM-1375". The FDA issued a decision of Substantially Equivalent on November 2, 1987. The device falls under product code HXB (Probe), 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 10, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Probe
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)
  • 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 HXB

  • K960539 — DIAO HAND SURGERY SET (July 23, 1996)
  • K943472 — COHORT AVB RETRACTOR SYSTEM (October 20, 1994)
  • K912843 — FLEXMEDICS RETRACT ORTH PROBE, PETTINE BONE PROBE (September 24, 1991)
  • K890227 — SURGICAL PROBE (January 27, 1989)
  • K873652 — HOOK PROBE #TM-1376 (November 2, 1987)
  • K863149 — BOWEN PROBE (September 5, 1986)
  • K841971 — 2.5MM & 4MM PROBE K841969-LABELING (June 19, 1984)
  • K840558 — SHUTT PRECISION PROBES (April 25, 1984)
  • K810294 — LINE CADDY (February 26, 1981)
  • K802951 — I.M PROBES (December 17, 1980)

FDA data resources